Medtronic 6972260 Instructions for Use

Instructions for Use 0381422E Rev. D

Prestige LP™ Cervical Disc

Medtronic Sofamor Danek USA, Inc.

1800 Pyramid Place Memphis, TN 38132
Tel. [phone] (In U.S.A.)

901 396 3133 (Outside of U.S.A.)

Fax [phone]

CAUTION: Federal (United States) law restricts this device to sale by or on the order of a

Physician.

HOW SUPPLIED

Prestige LP™ Cervical Disc Implants – Sterile
Surgical Instruments – Non-sterile (unless otherwise noted on the package label)

DEVICE DESCRIPTION

The Prestige LP™ Cervical Disc is a two-piece articulating device that is inserted into the
intervertebral disc space as a pre-assembled unit at one or two contiguous cervical levels using
an anterior approach. The device is manufactured from a titanium ceramic composite (Titanium­6Aluminum-4Vanadium with 10% Titanium Carbide) and consists of two metal plates which
function via a ball and trough mechanism. The superior component of the implant contains the
ball portion of the mechanism, and the inferior component contains the trough portion. These
two features engage to create an interface designed to allow for motion after implantation. Each
component is affixed to the adjacent vertebral body by two rail geometries incorporating anti­migration teeth, which are press fit into two pre-drilled holes in the vertebral bone. The portion
of the flat surface between the rails that contacts the vertebral endplate has a commercially pure
titanium (CP Ti) plasma thermal sprayed coating per ASTM F1580, designed to permit bony on­growth for additional device incorporation. The remaining portion of the flat surface is titanium
ceramic roughened to enhance fixation. Each component also contains two anterior tab features
designed to aid in device insertion and to minimize the risk of implanting the device too far into
the intervertebral space.

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Catalog Number

Size (Height x AP Dimension x ML Dimension)

6972250

5mm x 12mm x 15mm

6972450

5mm x 14mm x 15mm

6972650

5mm x 16mm x 15mm

6972260

6mm x 12mm x 17. 8m m

6972460

6mm x 14mm x 17. 8m m

6972660

6mm x 16mm x 17. 8m m

6972860

6mm x 18mm x 17. 8m m

6972470

7mm x 14mm x 17. 8m m

6972670

7mm x 16mm x 17. 8m m

6972870

7mm x 18mm x 17. 8m m

6972480

8mm x 14mm x 17. 8m m

6972680

8mm x 16mm x 17. 8m m

6972880

8mm x 18mm x 17.8mm

Figure 1a: Prestige LP™ Cervical Disc Figure 1b: Prestige LP™ Cervical

Disc at two contiguous levels

The Prestige LP™ Cervical Disc i s offered in a variety of configurations to accommodate varied
patient anatomy. The available components are shown in Table 1 below.

The Prestige LP™ Cervical Disc is designed to allow a minimum of 10 degrees lateral bending
(from neutral) and a minimum of 10 degrees flexion/extension (from neutral). The design is also
intended to allow unlimited axial rotation (constrained by ligaments and posterior elements) and
translation of 2mm in the sagittal plane.

Table 1: Prestige LP™ Cervical Disc Device Sizes

The Prestige LP™ Cervical Disc is implanted using instruments specific to the device, as well as
manual surgical instruments. Instruments specifically designed for implanting Prestige LP™
Cervical Disc consist of trials, trial cutter guides, rail punches, and implant inserters. General
purpose instruments include instruments for cervical distraction and discectomy preparation.

No warranties, expressed or implied, are made. Implied warranties of merchantability and fitness
for a particular purpose or use are specifically excluded.

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INDICATIONS FOR USE

The Prestige LP™ Cervical Disc is indicated in skeletally mature patients for reconstruction of
the disc from C3-C7 following discectomy at one level or two contiguous levels for intractable
radiculopathy (arm pain and/or a neurological deficit) with or without neck pain, or myelopathy
due to abnormality localized to the level of the disc space and at least one of the following
conditions confirmed by imaging (CT, MRI, X-rays): herniated nucleus pulposus, spondylosis
(defined by the presence of osteophytes), and/or visible loss of disc height as compared to
adjacent levels. The Prestige LP™ Cervical Disc is implanted using an anterior approach.
Patients should have failed at least 6 weeks of non-operative treatment or have had the presence
of progressive symptoms or signs of nerve root/spinal cord compression in the face of continued
non-operative management prior to implantation of the Prestige LP™ Cervical Disc.

CONTRAINDICATIONS

The Prestige LP™ Cervical Disc should not be implanted in patients with the following
conditions:

• Active systemic infection or localized infection at the surgical site;

• Osteoporosis or osteopenia defined as a DEXA bone mineral density T-score ≤ -1.0;

• Allergy or sensitivity to titanium, aluminum or vanadium;

• Marked cervical instability on neutral resting lateral or flexion/extension radiographs;

translation >3.5mm and/or >11° rotational difference from that of either level adjacent to
the treated levels;

• Severe spondylosis at the level to be treated, characterized by bridging osteophytes, loss

of disc height >50%, an absence of motion (<2°) as this may lead to a limited range of
motion and may encourage bone formation (e.g. heterotopic ossification, fusion);

• Severe facet joint arthropathy;

• Significant cervical anatomical deformity or clinically compromised vertebral bodies at

the affected level(s) due to current or past trauma (e.g., by radiographic appearance of
fracture callus, malunion or nonunion) or disease (e.g., ankylosing spondylitis,
rheumatoid arthritis); or

• Significant kyphotic deformity or significant reversal of lordosis.

WARNINGS

The Prestige LP™ Cervical Disc should only be used by surgeons who are experienced with
anterior cervical spinal procedures and have undergone adequate hands-on training in the use of
this specific device. Only surgeons who are familiar with the implant components, instruments,
procedure, clinical applications, biomechanics, adverse events, and risks associated with the
Prestige LP™ Cervical Disc should use this device. Medtronic will offer hands-on training to
physicians prior to their first use of the device. A lack of adequate experience and/or training
may lead to a higher incidence of adverse events, including neurological complications.

Correct sizing and placement of the device is essential to optimal performance. Information
regarding proper implant size selection, implant site preparation, and the use of instrumentation
before, during and after Prestige LP™ surgery is provided in the Prestige LP™ Cervical Disc
Surgical Technique manual. Users are advised to read and understand the surgical technique
manual and instructions for use prior to surgery.

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Due to the proximity of vascular and neurological structures to the implantation site, there are
risks of serious or fatal hemorrhage and risks of neurological damage with the use of this device.
Serious or fatal hemorrhage may occur if the great vessels are eroded or punctured during
implantation or are subsequently damaged due to breakage of implants, migration of implants, or
if pulsatile erosion of the vessels occurs because of close apposition of the implants. Care must
be taken to identify and protect these structures.

Heterotopic Ossification (HO) is a potential complication associated with artificial cervical discs
and could lead to reduced cervical motion.

Devices with metal-on-metal articulating surfaces (such as the Prestige LP™ Cervical Disc) may
release wear debris, metallic particles or metal ions locally near the device and/or systemically.
The short and long term effects of the wear debris, metallic particles and metal ions on the body
are not known, but certain groups of patients may be at a higher risk including patients who are
pregnant, patients who are planning to get pregnant, and patients who have renal disease.

PRECAUTIONS

The safety and effectiveness of this device has not been established in patients with the following
conditions:

• Axial neck pain as the solitary symptom;

• Skeletally immature patients, pediatric or adolescent children (<21 years old), or those

over the age of 78;

• Prior cervical spine surgery, including prior surgery at the index level or adjacent levels;

• More than two cervical discs or two non-adjacent cervical discs that require surgical

treatment;

• Facet joint pathology of involved vertebral bodies;

• Spinal metastases;

• An endocrine or metabolic disease that affects bones such as Paget’s disease,

osteomalacia, renal osteodystrophy, Ehlers-Danlos Syndrome, or osteogenesis
imperfecta;

• Chronic or acute renal failure or history of renal disease;

• Taking medications known to potentially interfere with bone/soft tissue healing (e.g.,

steroids);

• Diabetes mellitus requiring daily insulin management;

• Serious mental illness;

• Being treated for alcohol and/or drug abuse; and

• Pregnant.

Pre-operative

Patient selection is extremely important. In selecting patients for a total disc replacement, the
following factors may negatively affect the success of the procedure: the patient’s occupation or
activity level; prior injury or ongoing illness (e.g., Alzheimer’s disease, emphysema); alcoholism
or drug abuse; and certain degenerative diseases (e.g., degenerative scoliosis, ankylosing
spondylitis) that may be so advanced at the time of implantation that the expected useful life of
the device is substantially diminished.

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In order to minimize the risk of periprosthetic vertebral fractures, surgeons must consider all co­morbidities, past and present medications, previous treatments, etc. Surgeons should screen
patients to determine if a DEXA bone mineral density measurement is necessary. If DEXA is
performed, the patient should not receive the Prestige LP™ Cervical Disc (per the
contraindications listed above) if the DEXA bone mineral density T-score is ≤ -1.0, as the patient
may be osteoporotic or osteopenic.

The patient should be informed of the potential adverse effects (risk/complications) contained in
this insert (see POTENTIAL ADVERSE EFFECTS OF THE DEVICE ON HEALTH).

Preoperative planning may be used to estimate the required implant size and to assure that the
appropriate range of sizes is available for surgery. Specific preoperative planning is necessary
when performing a two-level procedure. The procedure should not take place if the appropriate
range of sizes will not be available.

Inspect all instruments prior to surgery and replace any worn or damaged items. Instruments
which have been used excessively may be more likely to break.

Intra-operative

Correct selection of the appropriate implant size is extremely important to ensure the placement
and function of the disc. When performing a two-level procedure, to ensure sufficient access to
the two affected disc spaces, make the skin incision centered at the middle vertebral body. A
standard incision for the exposure of two levels is required. See the surgical technique manual
for step-by-step instructions on the surgical technique, including determining the correct implant
size.

Use aseptic technique when removing the Prestige LP™ Cervical Disc components from the
innermost packaging. Carefully inspect each component and its packaging for any signs of
damage, including damage to the sterile barrier. Do not use Prestige LP™ Cervical Disc
components if the packaging is damaged or the implant shows signs of damage.

Use care when handling a Prestige LP™ Cervical Disc component to ensure it does not come in
contact with objects that could damage the implant. Exercise care to ensure implantation
instruments do not contact the highly polished articulating surfaces of the endplates. Damaged
implants are no longer functionally reliable. Visual inspection of the Prestige LP™ Cervical Disc
assembly is recommended prior to implantation. If any part of the assembly appears damaged, do
not use the device.

When preparing the disc space, remove anterior or posterior osteophytes as needed, taking care
to perform a complete discectomy while minimizing bone removal, as excessive bone removal
may weaken the vertebral endplates or vertebral body.

Correct positioning of the rail punch is critical prior to performing the rail preparation step. Care
should be taken to correctly position the rail punch during this step.

Ensure proper alignment and placement of the Prestige LP™ Cervical Disc as misalignment may
cause excessive wear and/or early failure of the device.

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In a two-level procedure, when placing the first implant, pay special attention to implant height
selection. The goal is to balance the discs to achieve normal sagittal balance and disc space
height. Before placing the first implant, it is important to verify normal sagittal balance and disc
space height by using the Implant Trials. Achieve this by preoperative templating, careful
trialing under lateral fluoroscopy, and comparing the facet and intradiscal heights in healthy
adjacent levels. Implant Trials should fit snugly without distracting the disc spaces.

The Prestige LP™ Cervical Disc components should not be used with components or
instruments of spinal systems from other manufacturers. See the surgical technique manual for
step-by-step instructions.

The Prestige LP™ Cervical Disc implants are designed for single patient use only. Do not re-use,
re-process, or re-sterilize the implants. Even if the device appears undamaged, re-use, re­processing, or re-sterilization may compromise the structural integrity of the implant and the
intended function of the device which could result in patient injury.

Post-operative

Patients in the clinical study of the Prestige LP™ Cervical Disc were instructed to use non­steroidal anti-inflammatory drugs (NSAIDs) for two weeks postoperatively. It has been reported
in the literature that short-term postoperative use of NSAIDs may reduce the instance of
heterotopic ossification (HO). To reduce the instance of HO, it is recommended that the Prestige
LP™ device be implanted in subjects able to tolerate the use of NSAIDs for two weeks post­operatively.

Patients should be instructed in postoperative care procedures and should be advised of the
importance of adhering to these procedures for successful treatment with the device. Patients
should be advised to avoid any activities that require repeated bending or twisting, heavy lifting,
and challenging activities such as athletic activities. Gradual increase in physical activity will
depend on individual patient progress.

MRI Safety Information

In non-clinical testing the Prestige LP™ Cervical Disc implanted at either a single level or two
contiguous levels was determined to be MR-conditional. A patient with this device can be
scanned safely, immediately after placement, under the following conditions:

• Static magnetic field of 1.5-Tesla and 3.0-Tesla.

• Maximum spatial gradient magnetic field of 3000-Gauss/cm or less.

• Maximum whole body average specific absorption rate (SAR) of 4.0 -W/kg or less under

Normal Operating Mode or first level controlled operating mode.

• Body Coil only.

Under the scan conditions defined above, the Prestige LP™ Cervical Disc is expected to produce
a maximum temperature rise of less than 4.0°C after 15 minutes of continuous scanning.

In non-clinical testing, the image artifact caused by the device extends approximately 20 mm
from the Prestige LP™ Cervical Disc when imaged with a gradient echo pulse sequence in a 3.0

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Tesla MRI system.
If the Prestige LP™ Cervical Disc is used in connection with any device which is not

MR Conditional, please be advised that this combination has not been tested in the MR
environment and, therefore, higher heating and possible injury to the patient may occur.

The presence of other implants or the health state of the patient may require a modification of the
MR conditions.

POTENTIAL ADVERSE EFFECTS OF THE DEVICE ON HEALTH

Below is a list of the potential adverse effects (e.g., complications) associated with the use of the
Prestige LP™ Cervical Disc identified from the Prestige LP™ Cervical Disc clinical study
results, approved device labeling for other cervical total disc replacement devices, and published
scientific literature including: (1) those associated with any surgical procedure; (2) those
associated with anterior cervical spine surgery; and (3) those associated with a cervical artificial
disc device, including the Prestige LP™ Cervical Disc. In addition to the risks listed below, there
is also the risk that surgery may not be effective in relieving symptoms, or may cause worsening
of symptoms. Additional surgery may be required to correct some of the adverse effects.

1. Risks associated with any surgical procedure include:

• Anesthesia complications including an allergic reaction or anaphylaxis;

• Infection (wound, local, and/or systemic) or abscess;

• Wound dehiscence or necrosis;

• Edema;

• Soft tissue damage or fluid collections, including hematoma or seroma;

• Pain/discomfort at the surgical incision and/or skin or muscle sensitivity over the incision

which may result in skin breakdown, pain, and/or irritation;

• Heart or vascular complications including bleeding, hemorrhage or vascular damage

resulting in catastrophic or potentially fatal bleeding, ischemia, myocardial infarction,
abnormal blood pressure, venous thromboembolism including deep vein thrombosis and
pulmonary embolism, thrombophlebitis, or stroke;

• Pulmonary complications including atelectasis or pneumonia;

• Impairment of the gastrointestinal system including ileus or bowel obstruction;

• Impairment of the genitourinary system including incontinence, bladder dysfunction, or

reproductive system complications;

• Neurological complications including nerve damage, paralysis, seizures, changes to

mental status, or reflex sympathetic dystrophy;

• Complications of pregnancy including miscarriage or congenital defects;

• Inability to resume activities of daily living; and

• Death.

2. Risks associated with anterior cervical spine surgery include:

• Injury to surrounding organs and structures including the spinal cord, nerve roots, other

neurologic structures adjacent to the spinal column, vocal cords, adjacent vertebrae,
lymphatic vessels, blood vessels, soft tissue, dura, the trachea, the esophagus, the larynx,
or the pharynx;

• Dysphagia, dysphonia, hoarseness, vocal cord paralysis, laryngeal palsy; or sore throat;

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• Tracheal, esophageal, or pharyngeal perforation, fistula, recurrent aspiration, or airway

obstruction;

• Neurological complications, including damage to nerve roots, the spinal cord, or other

nerves possibly resulting in muscle weakness or paralysis, changes in sensation
(including numbness, dysesthesias, or paresthesias), bowel/bladder dysfunction, or pain;

• Neck pain, arm pain, or headache;

• Dural tear or leak or cerebrospinal fistula;

• Discitis, arachnoiditis, or other type of inflammation;

• Loss of disc height; loss of anatomic sagittal plane curvature or vertebral listhesis, spinal

stenosis, or spondylolysis; and

• Scarring, herniation or degeneration of adjacent discs.

3. Risks associated with a cervical artificial disc device, including the Prestige LP™ Cervical

Disc, include:

• Risks directly related to the device including malposition, migration/displacement,

subsidence/loss of disc height, device breakage, device disassembly, or early or late
loosening of the device. Any of these issues may cause pain or injury to surrounding
organs and structures including the spinal cord, nerve roots, or other neurologic structures
adjacent to the spinal column (which could cause pain, paralysis, or numbness) or blood
vessel damage or erosion (which could cause catastrophic or fatal bleeding);

• Deterioration in neurologic status including muscle weakness or paralysis, changes in

sensation (including numbness, dysesthesias, or paresthesias), decreased reflexes, or loss
of bowel and/or bladder control;

• Development of new radiculopathy, myelopathy, or pain;

• Failure of the device to improve symptoms or function;

• Problems during placement of the device including trouble sizing the device, anatomical

or technical difficulties implanting the device, or issues with the device instruments (e.g.,
bending or breakage) including the possibility that a fragment of a broken instrument
may remain in the patient after implantation;

• Adverse reaction or allergy to the device materials (titanium, aluminum or vanadium),

device wear debris or metal ions which may lead to a systemic reaction or a local adverse
tissue reaction or chronic inflammation which may lead to implant loosening or failure of
the device, osteolysis, bone resorption, tumor formation, autoimmune disease, metallosis,
scarring, or other symptoms;

• Change in the alignment of the spine or loss of proper anatomic curvature, correction,

height or reduction of the spine including spondylolisthesis, change in lordosis, or
instability of the spine;

• Degeneration of other parts of the spine including the facet joints or adjacent discs;

• Fracture of the surrounding vertebrae;

• Unintended bone formation (i.e., heterotopic ossification) that may result in bridging

trabecular bone and may reduce spinal motion or result in unintended fusion at either the
treated level or adjacent levels;

• Device failure which may require a subsequent surgical intervention (including removal

of the Prestige LP™ Cervical Disc, revision, re-operation, or supplemental fixation); and

• Interference with radiographic imaging because of the presence of the implant.

NOTE: Some of the adverse effects listed above were observed in the Prestige LP™ Cervical

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Disc clinical studies. For detailed information on the specific adverse events that occurred in the
clinical studies of the Prestige LP™ Cervical Disc, please see Tables 8-10e and 12 for the
single-level study and Tables 31-33 and 35 for the two-level study.

PHYSICIAN NOTE: Although the physician is the learned intermediary between the company
and the patient, the important medical information given in this document should be conveyed to
the patient.

CLINICAL STUDIES

Two clinical studies were conducted to support the safety and effectiveness of the Prestige LP™
Cervical Disc for reconstruction of the disc from C3-C7 following discectomy at one level
(G040086) or two contiguous levels (G050202) for the indications outlined above. The clinical
studies are summarized separately below.

SUMMARY OF THE SINGLE-LEVEL IDE AND POST-APPROVAL STUDY (PAS)
METHOD

The clinical investigation of the Prestige LP™ Cervical Disc was conducted under an approved
IDE #G040086. The study was a prospective, multi-center, non-randomized, unmasked, non­inferiority clinical trial conducted in the United States to compare the safety and effectiveness of
the Prestige LP™ Cervical Disc to the standard of care (a legally marketed alternative with
similar indications for use) anterior cervical discectomy and fusion (ACDF) using structural
allograft and plate stabilization. The control group consisted of a non-randomized historical
control group that received treatment with ACDF for reconstruction of the disc from C3-C7
following single-level discectomy for intractable radiculopathy and/or myelopathy in the
previous IDE randomized trial of the Prestige™ Cervical Disc (#G010188).

The study consisted of 280 patients treated with the investigational device at 20 investigational
centers in the clinical trial, and 265 patients received the control treatment under a previous IDE
study. Fifty-four subjects were enrolled at the same investigational sites, including: 30 patients
enrolled into a Metal Ion Cohort (MI) for which metal ion analysis was conducted based on
blood draws at each follow-up time point; and, 24 Continued Access (CA) patients. A Post­Approval Study required as a condition of PMA approval was also conducted to follow the
original IDE subject cohort through 120 months postoperatively.

Study Objectives
IDE Study

The primary objective of the IDE study was to demonstrate that the overall success rate for the
investigational Prestige LP™ Cervical Disc treatment is statistically non-inferior to the overall
success rate of the control treatment at 24 months following surgery as determined by a
prespecified non-inferiority margin of 0.10. If statistical non-inferiority was established, the
investigational treatment is considered to be safe and effective, and the study was considered a
success.

Secondary objectives were to compare the success rates of individual effectiveness endpoints and
neurological status at 24 months following surgery. The secondary objectives included
demonstrating that the investigational group’s overall success rate was statistically superior to
the control group’s overall success rate at 24 months if the primary objective was met. Secondary

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objectives also included demonstrating the non-inferiority of the success rates of individual
effectiveness endpoints and neurological status at 24 months following surgery in the
investigational group as compared to that in the control group. If the non-inferiority of the
investigational group was established for a particular endpoint, then the superiority would be
tested for that endpoint as well. In addition, secondary objectives included comparing the rate of
adverse events and secondary surgeries between the two groups, and comparing the surgery and
hospital information between the two groups.

Post-Approval Study

The primary objective of the post-approval study (PAS) study was to demonstrate that the overall
success rate for the investigational group is statistically non-inferior to the success rate of the
control treatment at 84 months (7 years) following surgery. If statistical non-inferiority was
established, the investigational treatment is considered to be safe and effective and the study was
considered a success.

Secondary objectives were to compare the success rates of individual effectiveness endpoints and
neurological status at 24 months following surgery. The secondary objectives included
demonstrating that the investigational group’s overall success rate was statistically superiority to
the control group’s overall success rate at 84 months if the primary objective was met. Secondary
objectives also included demonstrating the non-inferiority of the success rates of individual
effectiveness endpoints and neurological status at 84 months following surgery in the
investigational group as compared to that in the control group. If the non-inferiority of the
investigational group was established for a particular endpoint, then the superiority would be
tested as well for that endpoint as well. In addition, secondary objectives included comparing the
rate of adverse event and secondary surgery between the two groups, and comparing the surgery
and hospital information between the two groups.

Study Desig ns
IDE Study

The IDE study was a multi-center, prospective, randomized, controlled clinical trial comparing
the investigational Prestige LP™ Cervical Disc treatment to the control treatment. Data were
collected at pre-operative, discharge, 6 weeks, 3 months, 6 months, 12 months (1 year) and at 24
months (2 years).

PAS Study

The post-approval study was a prospective study to continue follow-up on the subjects who
participated in the IDE study. Data were collected at 36 months (3 years), 60 months (5 years),
84 months (7 years) and 120 months (10 years-for the investigational group only) postoperative
to determine the long-term safety and effectiveness of the device.

Clinical Inc lus ion and E xclu sio n Criteria

To qualify for enrollment in the study, subjects met all of the following inclusion criteria and
none of the following exclusion criteria.

Clinical Inclusion Criteria

Enrollment in the Prestige LP™ study was limited to patients who met the following inclusion
criteria:

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• Cervical degenerative disc disease defined as: intractable radiculopathy and/or

myelopathy with at least one of the following items producing symptomatic nerve root
and/or spinal cord compression documented by patient history [e.g., pain, functional
deficit, and/or neurologic deficit and radiographic studies (e.g., computed tomography
(CT), magnetic resonance imaging (MRI), x-rays, etc.)]

o Herniated disc;
o Osteophyte formation

• One level requiring surgical treatment;

• C3-C4 disc to C6-C7 disc level of involvement;

• Unresponsive to non-operative treatment for approximately six weeks or has the presence

of progressive symptoms or signs of nerve root/spinal cord compression in the face of
continued non-operative management ;

• No previous surgical intervention at involved level or any subsequent, planned/staged

surgical procedure at the involved or adjacent level(s);

• Is at least 18 years of age, inclusive, at the time of the surgery;

• Preoperative Neck Disability Index score of ≥ 30;

• Has a preoperative neck pain score of ≥ 20 on Preoperative Neck and Arm Pain

Questionnaire;

• If a female of child-bearing potential, patient is not pregnant at the time of surgery;

• Is willing to comply with the study plan and sign the Patient Informed Consent Form.

Clinical Exclusion Criteria

Patients were not permitted to enroll in the Prestige LP™ study if any of the following exclusion
criteria were present:

• Has a cervical spinal condition other than symptomatic cervical disc disease requiring

surgical treatment at the involved level;

• Documented or diagnosed cervical instability defined by dynamic (flexion/extension)

radiographs showing sagittal plane translation > 3.5mm or sagittal plane angulation >
20°;

• More than one cervical level requiring surgical treatment;

• Has a fused level adjacent to the level to be treated;

• Has severe pathology of the facet joints of the involved vertebral bodies;

• Previous surgical intervention at the involved level;

• Has previous diagnosis of osteopenia or osteomalacia;

• Has any of the following that may be associated with a diagnosis of osteoporosis (if

“Yes” to any of the below risk factors, a DEXA Scan will be required to determine
eligibility):

o Postmenopausal non-Black female over 60 years of age and weighs less than 140

pounds

o Postmenopausal female that has sustained a non-traumatic hip, spine, or wrist

fracture

o Male over the age of 70
o Male over the age of 60 that has sustained a non-traumatic hip or spine fracture

If the level of bone mineral density (BMD) is a T score of -3.5 or a T score of -2.5 with
vertebral crush fracture, the patient is excluded from the study

• Has presence of spinal metastases;

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• Has overt or active bacterial infection, either local or systemic;

• Has severe insulin dependent diabetes;

• Has chronic or acute renal failure or prior history of renal disease;

• Has fever (temperature > 101°F oral) at the time of surgery;

• Has a documented allergy or intolerance to stainless steel, titanium, or a titanium alloy;

• Is mentally incompetent (if questionable, obtain psychiatric consult);

• Is a prisoner;

• Is pregnant;

• Is an alcohol and/or drug abuser currently undergoing treatment for alcohol and/or drug

abuse

• Has received drugs which may interfere with bone metabolism within two weeks prior to

the planned date of spinal surgery (e.g., steroids or methotrexate) excluding routing
perioperative anti-inflammatory drugs;

• Has a history of an endocrine or metabolic disorder known to affect osteogenesis (e.g.,

Paget’s Disease, renal osteodystrophy, Ehlers-Danlos Syndrome, or osteogenesis
imperfecta);

• Has a condition that requires postoperative medications that interfere with the stability of

the implant, such as steroids. (This does not include low dose aspirin for prophylactic
anticoagulation), excluding routine perioperative anti-inflammatory drugs;

• Has received treatment with an investigational therapy within 28 days prior to

implantation surgery or such treatment is planned during the 16 weeks following
implantation with the Prestige LP™ device.

Study Population

The studies included 280 non-randomized investigational subjects in the IDE study, 30 subjects
in Metal Ion (MI) cohort, and 24 subjects in Continued Access (CA) cohort. The studies also
included 265 historical control subjects in the IDE study.

Postoperative Care

The recommended post-operative care included avoidance of overhead lifting, heavy lifting,
repetitive bending, and high-impact exercise or athletic activity for 60 days postoperatively.
Avoidance of prolonged (beyond 2 weeks post-op) non-steroidal anti-inflammatory drug
(NSAID) use was specified in the postoperative regimen, although the use of NSAIDs was
recommended for the first two weeks post-operatively. Post-operative bracing requirements were
left to the discretion of the investigators and included the option for use of a soft collar as
needed. The use of electrical/external bone growth stimulators was not recommended during the
24 month follow-up period. However, in a few cases where an electrical/external bone growth
stimulator was utilized due to specific patient presentation, they were considered a supplemental
form of therapy for spinal fusion surgery, and deemed failures included in the “Supplemental
Fixation” Adverse Event category. Patients who smoked were encouraged to discontinue
smoking.

Study Visits and Length of Follow-Up

For the IDE study, patients were evaluated preoperatively (within 6 months of surgery),
intraoperatively, and postoperatively at 6 weeks, 3, 6, 12, 24 months, and annually thereafter
until the last subject enrolled in the study had been seen for their 24-month evaluation. For the

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Procedure

Pre-/Peri-Operative

Postoperative

Surgery/

Discharge

Preoperative Information

Confirm Patient Eligibility

X

Obtain Informed Consent

X

Obtain HIPAA Authorization

X

Case Report Forms

Patient Enrollment

X

Patient Qualification

X

Preoperative Data

X

Prior History Questionnaire

X

Neurological Status

X X X X X X

Preoperative Gait Assess men t an d Foraminal

Compression Test

X

Preoperative Patient Survey

X

Preoperative Neck Disability Index

X

Preoperative Neck and Arm Pain Questionnaire

X

Health Status Questionnaire (SF-36)

X X X X

Surgery Data

X

Hospital Discharge

X

Postoperative Data

X X X X X

Postoperative Patient Survey

X X X X X

Neck Disability Index

X X X X X

Postoperative Neck and Arm Pain Questionnaire

X X X X X

Postoperative Gait Assessment and Foraminal

Compression Test

X X X X X

Adverse Event Form (if any)

X X X X X X

Outstanding (Unresolved) Adverse Event (if any)

X X X X X X

Patient Disposition

X X X X X

Imaging – Radiographs and Scans*

Anterior/Posterior X-ray

X X X X X X X

Lateral X-ray

X X X X X X X

Right/Left Lateral Bend X-rays

X X X X X X

Flexion/Extension X-rays

X X X X X X

CT and/or MRI

X

DEXA Scan **

X

PAS, patients were evaluated at 36, 60, 84 and 120 months. Complications and adverse events
were evaluated over the course of the clinical trial. The length of follow-up for individual
subjects was up to 120 months (10 years). At each evaluation timepoint, the primary and
secondary clinical and radiographic outcome parameters were evaluated as shown in Table 2.
Success was determined from data collected up to 84 months.

Table 2: Schedule of Study Assessments

Pre-OP

Hospital

6 wks ±2

wks

3 mo. ±2

wks

6 mo. ± 1

mo.

12 mo. ±

2mo.

24 mo. ± 2 mo.

& Beyond

* Patients who sign cons ent and are screened eligibl e, but who do not receive the Prestige LP™ device, were not required to ha ve t he
preoperative radiographs obtained and forwarded to Medtronic.
** A DEXA Scan was only required if the patient had a risk factor that may be associated with a diagnosis of osteoporosis.

Data Source

New data collection

IDE and PAS Key Study Endpoints

The safety of the Prestige LP™ Cervical Disc was assessed by comparison to the historical
control group with respect to the nature and frequency of adverse events, secondary surgical
procedures, as well as maintenance or improvement in neurological status.

The effectiveness of the Prestige LP™ Cervical Disc device was assessed using a composite
definition of study success. The primary endpoint used for assessment of effectiveness was
improvement in Neck Disability Index (NDI) pain/disability scores.

Medtronic Page 13 of 103

In addition, several radiograph-assisted assessments were considered in evaluating both safety
and effectiveness including device subsidence, functional spinal unit (FSU) height maintenance,
device migration, and device breakage.

According to the final IDE and PAS protocol, an individual patient in either treatment group was
considered an overall success if the following criteria were met at 24 months for the IDE and 84
months for the PAS:

• An improvement (reduction) of at least 15 points from the baseline Neck Disability Index

score;

• Maintenance or improvement in neurological status;

• Disc height (Functional Spinal Unit Height) success (FSU success)

• No severe adverse event classified as implant-associated, surgical procedure-associated, or

implant/surgical procedure-associated; and

• No additional surgical procedure classified as “Failure”

An alternative analysis of the primary endpoint analysis was also conducted without the addition
of FSU height as a success criterion.

Secondary endpoints, measured in both treatment groups, included Radiographic Success, neck
pain (VAS), arm pain (VAS), quality of life (SF-36 PCS and MCS scores), patient satisfaction,
patient global perceived effort, gait assessment (Nurick’s classification), and foraminal
compression test. Additional measurements recorded were adjacent level stability, return to
work, and doctor’s perception of results. Radiographic Succcess for maintenance of motion is
defined as >4° but <=20° of angular motion based on lateral flexion/extension radiographs and
no radiographic evidence of bridging trabecular bone that forms a continuous bony connection
with the vertebral bodies (bridging bone).

Criteria for the success of the control group was defined in a previous IDE study (G010188).
Briefly, the same success criteria for the primary endpoints exist for the control group as the
investigational group, with the exception that the secondary endpoint for radiographic success
was defined by radiographic evidence of bone spanning the two vertebral bodies, existence of
angular motion stability <=4°, and no radiolucent lines covering more than 50% of the implant
surface.

Total number of Enrolled Study Sites and Subjects, Follow-up Rate

A total of 24 investigators and sub-investigators participated at 15 investigational sites in the
United States. The subject accountability data (includes subjects evaluated and percent follow-up
rate) are summarized in Table 3. Please note that Continued Access Cohort (CA) and the Metal
Ion Cohort (MI) were enrolled separately from the IDE Cohort at the same study sites. Safety
and effectiveness data were collected for the IDE, Safety (IDE+CA+MI), and ACDF Control
Cohorts while the statistical analyses were performed with the IDE Cohort in comparison to the
control group.

Medtronic Page 14 of 103

IDE 12 Months

IDE 24 Months

PAS 84 Months

PAS 120 Months

restige

IDE Cohort ACDF

Control

restige

Safety Cohort

restige

IDE Cohort ACDF

Control

restige

Safety Cohort

restige

PAS

ACDF

Control

restige

Safety Cohort

restige

PAS

ACDF

ontrol

restige

Safety Cohort

Enrolled

280

265

333

280

265

333

280

265

333

280 - 333

Theoretica l F ollow-up

280

265

333

280

265

333

280

265

333

280 - 333

Cumulative D eaths1

0 1 0 0 2 0 3 5 3 4 - 5 Cumulative Wi th drawals

1 6 1 1 8 1 9

13

12

12 - 16

Cumulati ve L ost-to­Follow Up

Expected2

279

244

332

278

235

331

258

196

305

254 - 299

Evaluabl e for Overall

(% of Total Expected)

Evaluabl e for Overall

(% of Total Expected)

Percent Follow-up

98.6%

94.7%

98.8%

97.8%

96.6%

98.2%

82.2%

95.4%

84.6%

90.9%

-

92.3%

Prestige LP™ IDE/PAS

(N=280)

p-value

Control)

Age (years)

44.5 ± 8.8

Range: 23 - 78

43.9 ± 8.8

Range: 22 – 73

43.8 ± 9.0

Range: 23 – 78

Table 3: Subject Accountability

Number of Patients

Success

Success, In Window

LP™

P

0 14 0 1 20 1 10 51 13 10 - 13

274

(98.2%)

271

(98.9%)

223

(91.4%)

206

(92.4%)

LP™

P

327

(98.5%)

322

(98.5%)

LP™

P

271

(97.5%)

262

(96.7%)

220

(93.6%)

201

(91.4%)

LP™

P

323

(97.6%)

310

(96.0%)

LP™

Cohort

P

211

(81.8%)

186

(88.2%)

182

(92.9%)

159

(87.4%)

LP™

P

257

(84.3%)

231

(89.9%)

LP™

Cohort

P

230

(90.6%)

219

(95.2%)

In addition to the study subjects described above, nineteen (19) subjects were consented but
declined participation in the study prior to receiving the assigned treatment. The demographic
and preoperative characteristics of the subjects who declined to participate in this study were
comparable to the patients included in this study.

Study Population Demographics and Baseline Parameters
Table 4 presents the summary statistics for demographic and baseline characteristics for the

Prestige LP™ IDE/PAS Cohort, the ACDF Control, and Prestige LP™ Safety Cohort. The
demographics of the study population are consistent with the demographics reported for prior
cervical artificial disc studies conducted in the U.S.

The investigational and control treatment groups were very similar demographically, and there
were no statistically significant differences (p<0.05) for any of the variables except for the use of
tobacco and race. Current tobacco use was higher in the control group (34.7% versus 26.4%) as
compared to the IDE/PAS Cohort. However, tobacco use was established through use of patient
questionnaires which utilized a binary response (i.e., yes or no), and quantification of the extent
or history of tobacco use was not established. Therefore, it is not possible to definitively
ascertain whether there were any substantial confounding effects from tobacco use on patient
outcomes. Regarding race differences among cohorts, there was a higher percentage of
Caucasian subjects in the IDE/PAS Cohort compared to the control group (96.8% versus 91.7%).

Table 4: Study Patient Demographics and Baseline Characteristics

Variables

Cohort

ACDF Control

(N=265)

Prestige LP™ Safety

Cohort (N=333)

(IDE/PAS vs.

LP™

C

P

275

-

(92.0%)

262

-

(95.3%)

1

Cumulative deaths are t he total number of deaths of stud y patients at th e 12, 24, 84 and 120-month tim e po i n ts . However, non e of th e

deaths were believed to be in any way related to the study treatment.

2

Expected = Theoretical minus Cumulative Deaths minus Cumulative Withdrawals minus Cumulative Lost Follow-Up

Medtronic Page 15 of 103

0.369

Height (inches)

67.7 ± 4.1

Range: 60.0 – 77.0

67.5 ± 4.2

Range: 58.0 – 80.0

67.7 ± 4.0

Range: 60.0 – 77.0

Weight (lbs.)

186.9 ± 45.0

Range: 100.0 – 340.0

184.7 ± 41.5

Range: 98.0 – 328.0

187.3 ± 45.2

Range: 100.0 – 340.0

BMI (kg/m2)

28.5 ± 5.6

Range: 17.2 – 48.2

28.3 ± 5.1

Range: 19.0 – 53.5

28.5 ± 5.6

Range: 17.2 – 48.2

Sex

Female (%)

151 (53.9%)

143 (54.0%)

178 (53.5%)

Race

Other

1 (0.4%)

1 (0.4%)

1 (0.3%)

Marital Status

Widowed

2 (0.7%)

2 (0.8%)

3 (0.9%)

Education Level

> High School

206 (74.1%)

173 (65.5%)

236 (71.3%)

Previous Neck Surgery

No

277 (98.9%)

263 (99.2%)

330 (99.1%)

Preoperative Medication use

Muscle Relaxants

100/279 (35.8%)

114/264 (43.2%)

123/332 (37.0%)

0.095

Preoperative Pain Status3

Neck Pain Only

25 (8.9%)

26 (9.8%)

34 (10.2%)

Worker’s Compensation

32/280 (11.4%)

35/365 (13.2%)

54/333 (16.2%)

0.602

Unresolved Spinal Litigation

34/280 (12.1%)

32/265 (12.1%)

61/333 (18.3%)

1.000

Current Tobacco Use

74/280 (26.4%)

92/265 (34.7%)

94/333 (28.2%)

0.041

Current Alcohol Use

150/280 (53.6%)

141/265 (53.2%)

172/333 (51.7%)

1.000

Preoperative Work Status

188/280 (67.1%)

166/265 (62.6%)

217/333 (65.2%)

0.282

Duration of S ymptoms

> 6 mos.

173 (61.8%)

161 (60.8%)

212 (63.7%)

0.622

0.567

0.722

Male (%)

Caucasian
Black
Asian
Hispanic

Single
Married
Divorced
Separated

< High School
High School

Yes

Non-Narcotics
Weak Narcotics
Strong Narcotics

Arm and Neck Pain
Arm Pain Only

129 (46.1%)

271 (96.8%)

7 (2.5%)
0 (0.0%)
1 (0.4%)

40 (14.3%)

189 (67.5%)

42 (15.0%)

7 (2.5%)

15 (5.4%)

57 (20.5%)

3 (1.1%)

208/280 (74.3%)
133/279 (47.7%)

62/279 (22.2%)

255 (91.1%)

0 (0.0%)

122 (46.0%)

243 (91.7%)

13 (4.9%)

2 (0.8%)
6 (2.3%)

32 (12.1%)

204 (77.0%)

24 (9.1%)

3 (1.1%)

14 (5.3%)

77 (29.2%)

2 (0.8%)

187/263 (71.1%)
127/263 (48.3%)

58/264 (22.0%)

238 (90.2%)

0 (0.0%)

155 (46.5%)

320 (96.1%)

10 (3.0%)

1 (0.3%)
1 (0.3%)

47 (14.1%)

224 (67.3%)

51 (15.3%)

8 (2.4%)

17 (5.1%)

78 (23.6%)

3 (0.9%)

246/333 (73.9%)
152/332 (45.8%)

68/332 (20.5%)

299 (89.8%)

0 (0.0%)

1.000

0.043

0.096

0.062

1.000

0.441

0.931

1.000

0.769

< 6 wks.
6 wks. – 6 mos.

The mean baseline pre-operative assessments for the Prestige LP™ IDE/PAS Cohort, Control
Group, and Prestige LP™ Safety Cohort are presented in Table 5. There were no statistical
differences between the Prestige LP™ IDE/PAS Cohort and Control for NDI, SF-36 PCS, SF-36
MCS, neck pain, and arm pain. There were statistically significant differences in baseline motor
neurologic status (38.2% - Prestige LP™ IDE/PAS Cohort; 59.5% - Control) and mean cervical
range of motion (5.67º - Prestige LP™ IDE/PAS Cohort; 7.87º - Control). However, after

3

Arm pain is defined as a subject having an arm pain score ≥20 and neck pain is defined as a subject having a neck pain score

≥20. If a subject has both an arm pain score ≥20 and a neck pain score ≥20, then this subject is considered as having “Arm and
Neck Pain”; if a subject has a neck pain score ≥20 and an arm pain score < 20, then this subject is considered as having “Neck
Pain Only”; if a subject has an arm pain score ≥20 and a neck pain score < 20, then this subject is considered as having “Arm
Pain Only”. Since neck pain score ≥20 is an inclusion criteria, there are no subjects with “Arm Pain Only”.

Cervical Disc is indicated in skeletally mature patients for reconstruction of the disc at one level from C3-C7 following single­level discectomy for in tractable radiculopathy ( arm pain and/or a neurological deficit) with or without neck pain and is not
indicated for treatment of isolated neck pain. No patients were included into the study with neck pain without any other
symptoms.

Medtronic Page 16 of 103

22 (7.9%)

85 (30.4%)

15 (5.7%)

89 (33.6%)

24 (7.2%)

97 (29.1%)

0.494

The Prestige LP™

p-value (IDE/PAS

Control)

55.5 ± 14.7

Range: 30.0 – 98.0

56.4 ± 15.9

Range: 26.0 – 100.0

56.6 ± 15.0

Range: 30.0 – 98.0

32.2 ± 7.4

Range: 14.3 – 57.9

32.0 ± 7.5

Range: 7.9 – 56.0

32.3 ± 7.1

Range: 14.3 – 57.9

44.5 ± 11.5

Range: 16.5 – 68.3

42.7 ± 12.4

Range: 14.1 – 70.8

43.8 ± 11.9

Range: 16.5 – 68.3

67.0 ± 20.8

Range: 20.0 – 100.0

69.3 ± 21.5

Range: 20.0 – 100.0

68.0 ± 20.8

Range: 20.0 – 100.0

59.6 ± 26.3

Range: 0.0 – 100.0

62.4 ± 28.5

Range: 0.0 – 100.0

59.0 ± 27.1

Range: 0.0 – 100.0

• Overall4

64/280 (22.9%)

79/264 (29.9%)

73/333 (21.9%)

0.065

5.67 ± 3.69

Range: 0.27 – 18.10

7.87 ± 4.32

Range: 0.74 – 21.34

5.88 ± 3.78

Range: 0.27 – 19.47

0.26 ± 0.25

Range: 0.00 – 1.64

Posterior Mean and 95% BCI5 of the

(lower, upper)

Spinal Level Treated

C34 (%)

4 (1.4%)

10 (3.8%)

4 (1.2%)

N/A

C45 (%)

21 (7.5%)

15 (5.7%)

28 (8.4%)

N/A

C56 (%)

147 (52.5%)

149 (56.2%)

178 (53.5%)

N/A

C67 (%)

108 (38.6%)

91 (34.3%)

123 (36.9%)

N/A

Operative time (hrs)

1.5 ± 0.6

(n=280)

1.4 ± 0.5

(n=265)

1.4 ± 0.5

(n=333)

propensity score adjustments, the variables appeared balanced between groups. Thus, differences
in baseline symptoms were adjusted for in the analysis and are therefore unlikely to have led to
significant bias in the reported results.

Table 5: Preoperative Evaluation of Endpoints

Variables

NDI

SF-36 PCS

SF-36 MCS

Neck Pain Score

Arm Pain Score

Prestige LP™ IDE/PAS Cohort

(N=280)

ACDF Control

(N=265)

Prestige LP™ Safety Cohort

(N=333)

Cohort vs ACDF

0.498

0.777

0.079

0.191

0.236

Neurological Status (normal)

• Motor

• Sensory

• Reflexes

Baseline ROM angulation (º)

Baseline ROM translation (mm) N/A

107/280 (38.2%)
117/280 (41.8%)
186/280 (66.4%)

157/264 (59.5%)
134/264 (50.8%)
161/264 (61.0%)

135/333 (40.5%)
147/333 (44.1%)
200/333 (60.1%)

N/A N/A

< 0.001

0.039

0.212

< 0.001

Surgery and Hospitalization
Table 6 summarizes the information related to the surgical procedures and postoperative

hospitalizations of subjects. The most common treated surgical levels were C5-C6 and C6-C7.
The mean operative times for the IDE/PAS and control treatment groups were 1.5 hours and 1.4
hours, respectively, which is a mean difference of 0.1 hours, or 6 minutes and is unlikely to
represent any significant clinical difference. Additionally, investigational subjects were found to
have similar estimated blood loss to the control group subjects (50.5 ml for IDE/PAS cohort and

49.4 ml for Safety cohort versus 57.5 ml for control group). The median blood loss was 35 ml for
the IDE/PAS cohort versus 50 ml for both the Safety and control groups. The mean hospital
stays of subjects in all treatment groups were similar (1.0 days for all groups). Table 7
summarizes the Prestige LP™ device implanted by size and level.

Table 6: Surgical Data

Prestige LP™

IDE/PAS Cohort

(N=280)

ACDF Control

(N=265)

Prestige LP™ Safety

Cohort

(N=333)

Difference of Mean between IDE/PAS

Cohort and Control Group

4

If at least one of the three components (motor, sensory, reflexes) is not normal, then overall is defined as “not normal”, if all the

components are nor mal, then overall is defined as “normal”

5

BCI = Bayesian HPD Credible Interval

Medtronic Page 17 of 103

Range: 0.7 – 3.4

Range: 0.6 – 3.4

Range: 0.7 – 3.4

0.11 (0.02, 0. 22)

Blood Loss (m l)

50.5 ± 73.5

(n=278)

57.5 ± 68.1

(n=263)

49.4 ± 67.9

(n=333)

Hospitaliz ation (days)

1.0 ± 0.5

(n=280)

1.0 ± 0.5

(n=265)

1.0 ± 0.4

(n=333)

Median Return to Work
Time (days)

6mm x 12mm Disc (%)

6mm x 14mm Disc (%)

132

(39.6%)

6mm x 16mm Disc (%)

6mm x 18mm Disc (%)

7mm x 12mm Disc (%)6

7mm x 14mm Disc (%)

7mm x 16mm Disc (%)

7mm x 18mm Disc (%)

8mm x 12mm Disc (%)

8mm x 14mm Disc (%)

8mm x 16mm Disc (%)

8mm x 18mm Disc (%)

4

(1.4%)

21

(7.5%)

147

(52.5%

108

(38.6%)

280

(100.0%)

4

(1.2)

28

(8.4%)

178

(53.5%)

123

(36.9%)

333

(100.0%)

Range: 3.0 – 700.0

Median: 35.0

Range: 0.0 – 3.0

40 61 42 N/A

Range: 0.0 – 700.0

Median: 50.0

Range: 0.0 – 4.0

Range: 3.0 – 700.0

Median 50.0

Range: 0.0 – 3.0

-4.7 (-16.8, 7.9)

0.03 (-0.0 5, 0. 11)

Table 7: All Prestige LP™ Devices Implanted by Size and Level

Prestige LP™ IDE/PAS Cohort Prestige LP™ Safety Cohort
C3-C4 C4-C5 C5-C6 C6-C7 Total C3-C4 C4-C5 C5-C6 C6-C7 Total

1 4 15 11 31 (11.1%) 1 8 28 12 49(14.7%)
1 10 65 37 113 (40.4%) 1 13 76 42
2 1 35 23 61 (21.8%) 2 1 37 23 63 (18.9%)

0 0 0 0 0 (0.0%) 0 0 0 0 0 (0.0%)
0 0 1 1 2 (0.7%) 0 0 1 2 3 (0.9%)
0 2 5 8 15 (5.4%) 0 2 9 11 22 (6.6%)
0 4 16 9 29 (10.4%) 0 4 17 12 33 (9.9%)
0 0 9 11 20 (7.1%) 0 0 9 11 20 (6.0%)
0 0 0 0 0 (0.0%) 0 0 0 0 0 (0.0%)
0 0 0 3 3 (1.1%) 0 0 0 4 4 (1.2%)
0 0 1 4 5 (1.8%) 0 0 1 5 6 ( 1.8%)
0 0 0 1 1 (0.4%) 0 0 0 1 1 (0.3%)

Total (%)

SUMMARY OF THE IDE AND POST-APPROVAL STUDY (PAS) RESULTS

Final Safety Findings (Key Endpoints)

The analysis of safety was based on the as-treated cohort of 598 total patients with surgery (333
Prestige LP™ “Safety” subjects consisting of 280 Prestige LP™ IDE/PAS Cohort subjects, as
well as 54 subjects from the Continued Access (CA) and Metal Ion (MI) Cohorts7; and 265
ACDF control subjects). This was a non-randomized study and the ACDF group was a historical
control. A summary of the total number of adverse events (AE) is shown in Table 8. Adverse
events were classified by the independent Clinical Adjudication Committee (CAC) for severity
and relationship to the device and/or surgical procedure.

6

The 7mm x 12mm Prestige LP™ Cervical Disc was a part of the size offerings in the IDE/PAS study, but is not a part

of the size offerings available for market.

7

One Metal Ion Cohort subject was also an IDE Cohort s ubject.

Medtronic Page 18 of 103

Posterior

Control9

Patients (%)

257 (91.8%)

219 (82.6%)

307 (92.2%)

271 (96.8%)

232 (87.5%)

323 (97.0%)

275 (98.2%)

327 (98.2%)

Events
(Events/Patient)

Device or

Patients (%)

73 (26.1%)

69 (26.0%)

80 (24.0%)

75 (26.8%)

70 (26.4%)

83 (24.9%)

75 (26.8%)

83 (24.9%)

Table 8: Summary of Adverse Events Up to the 120 Month Time Interval

IDE 24 Month PAS 84 Month PAS 120 Month

Adverse Event

Type

All Adverse
Events (AEs)

Device/Surgical
Procedure Related
AEs

Surgical
Procedure Related
AEs Only

Severe Adverse
Events
(Grade 3 or 4)

Severe Device or
Device/Procedure

-Related AEs
(Grade 3 or 4)

Prestige

Measure

Patients (%) 34 (12.1%) 41 (15.5%) 41 (12.3%)

Events
(Events/Patient)

Events
(Events/Patient)

Patients (%) 126 (45.0%) 96 (36.2%) 157 (47.1%)
Events

(Events/Patient)
Patients (%) 13 (4.6%)

Events
(Events/Patient)

LP™

IDE Cohort

(N=280)

1581 (5.65) 1225 (4.62) 1901 (5.71) 2774 (9.91) 2236 (8.44) 3384 (10.16) 3523 (12.58) 4276 (12.84)

66 (0.24) 73 (0.28) 76 (0.23) 99 (0.35) 86 (0.32) 114 (0.34) 114 (0.41) 135 (0.41)

141 (0.50) 117 (0.44) 148 (0.44) 144 (0.51) 118 (0.45) 152 (0.46) 144 (0.51) 152 (0.46)

409 (1.46) 257 (0.97) 500 (1.50) 762 (2.72) 507 (1.91) 955 (2.87) 1025 (3.66) 1258 (3.78)

33 (0.12)

31 (0.12) 33 (0.10) 48 (0.17) 31 (0.12) 48 (0.14) 54 (0.19) 54 (0.16)

ACDF
Control
(N=265)

14 (5.3%) 13 (3 .9% ) 17 (6.1%) 14 (5.3%) 17 (5.1%)

Prestige

LP™

Safety

Cohort

(N=333)

Mean and

95% BCI8 of

the

Difference of

Event Rate

between IDE

Cohort and

ACDF

10.2%

(4.3%, 16.4%)

-3.0%

(-9.5%, 3.0%)

0.8%

(-7.6%, 8.3%)

10.6%

(1.4%, 19.4%)

Prestige

LP™

PAS Cohort

(N=280)

49 (17.5%) 44 (16.6%) 61 (18.3%)

174 (62.1%) 139 (52.5%) 215 (64.6%)

ACDF
Control
(N=265)

Prestige

LP™

Safety

Cohort

(N=333)

Posterior M ean

and 95% BCI10 of

the Difference of

Event Rate

between PAS

Cohort and ACDF

Control11

9.0%

(4.2%, 13.9%)

1.7%

(-5.3%, 8.8%)

0.9%

(-6.7%, 9.5%)

8.1%

(-1.3%, 16.9%)

0.9%

(-3.2%, 5.2%)

Prestige

LP™

PAS Cohort

(N=280)

56 (20.0%) 73 (21.9%)

191 (68.2%) 236 (70.9%)

21 (7.5%) 21 (6.3)

Prestige LP™
Safety Cohort

(N=333)

8

BCI = Bayesian HPD Credible Interval

9

95% BCI of the difference of the event rate between the investigational group and control group was only determined for the “All Adverse Events” category because the analysis

was pre-defined. All other analyses were not pre-defined.

10

BCI = Bayesian HPD Credible Interval

11

95% BCI of the difference of the event rate between the investigational group and control group was only determined for the “All Adverse Events” category because the anal ysis

was pre-defined. All other analyses were not pre-defined.

Medtronic Page 19 of 103

Level

(N=280)

(N=265)

(N=333)

Point Estimate

Cohort

(N=280)

(N=265)

(N=333)

Point Estimate

Cohort

4/4

(100%)

9/10

(90.0%)

4/4

(100.0%)

10.0%

(-19.9%, 39.9 % )

4/4

(100%)

9/10

(90.0%)

4/4

(100.0%)

10.0%

(-19.9%, 39.9 % )

20/21

(95.2%)

12/15

(80.0%)

27/28

(96.4%)

15.2%

(-5.6%, 36.1%)

21/21

(100%)

12/15

(80.0%)

28/28

(100.0%)

20.0%

(1.7%, 38.3%)

135/147
(91.8%)

124/149
(83.2%)

163/178
(91.6%)

8.6%

(1.1%, 16.2%)

142/147
(96.6%)

131/149
(87.9%)

172/178
(96.6%)

8.7%

(2.6%, 14.8%)

98/108

(90.7%)

74/91

(81.3%)

112/123
(91.1%)

9.4%

(-0.1%, 19.0%)

104/108
(96.3%)

80/91

(87.9%)

119/123
(96.7%)

8.4%

(1.0%, 15.7%)

Table 9 provides summary data on the number of adverse events in each treatment group by
treatment level, including post-hoc statistical analysis and comparison between the Prestige LP™
IDE/PAS Cohort and the ACDF control group through the 24- and 84- month time points using
Frequentist methods. The percentage of subjects with adverse events was not statistically
different between the two groups at 24 months for all levels except for C5-C6; however, this
difference was not clinically meaningful. The percentage of subjects with adverse events was
statistically different between the two groups at 84 months for all levels except for C3-C4.

Table 9: Summary of Total Adverse Events by Level Treated through Month 24 IDE and

84 PAS and Safety Population

IDE 24 Month PAS 84 Month

Treatment

C3-C4

C4-C5

C5-C6

C6-C7

Prestige

LP™

IDE

Cohort

ACDF

Control

Prestige

LP™

Safety

Cohort

and 95%

Confidence

Interval12 of
Difference of
Adverse Rate
between IDE

Cohort and

ACDF Control

Prestige

LP™

IDE Cohort

ACDF

Control

Prestige

LP™

Safety

Cohort

and 95%

Confidence

Interval13 of

Difference of

Adverse Rate

between IDE

Cohort and

ACDF Control

Tables 10a and 10b report adverse events from all patients to establish the safety profile of the

device. Tables 10c to 10e report adverse events classified as device related or device/surgical
procedure-related. Adverse events are listed in alphabetical order. Adverse event rates are based
on the number of patients having at least one occurrence of an adverse event, divided by the
number of patients in that treatment group. Subjects experiencing adverse events in more than
one category are represented in each category in which they experienced an adverse event.

24 Months The overall adverse event rate was higher for subjects treated with the Prestige LP™ device (IDE Cohort, 91.8%; Safety Cohort, 92.2%) compared to the Control (82.6%) through 24 months. At 24 months, the adverse event rate between the Prestige LP™ IDE Cohort and the Control was statistically different with the 95% BCI for the difference of adverse events rates between the Prestige LP™ IDE Cohort and the ACDF Control Cohort being (4.3%, 16.4%), excluding 0. However, when comparing device-related adverse events, the rates are comparable. Although the rate of Prestige LP™ IDE subjects having at least one adverse event was statistically higher than the control group rate, the difference in adverse event rates was not considered to be clinically meaningful and this finding may be attributable to the higher follow-up rates (and potentially, higher reporting of events) for investigational subjects as compared to the ACDF control subjects. Specifically, note that the 24-month follow-up rates are 97.8% and 96.6% respectively

12

The 95% CI was provided using Fr e que ntist Farringt on a nd Ma nning methods

13

The 95% CI was provided using Frequentist Farrington and Manning methods

Medtronic Page 20 of 103

for the Prestige LP™ IDE Cohort and ACDF Control Cohort. Table 11 lists the brief definitions
for all adverse events.

84 Months The overall adverse event rate was higher for subjects treated with the Prestige LP™ device (PAS Cohort, 96.8%; Safety Cohort, 97.0%) compared to the Control (87.5%) through 84 months. This included a higher cumulative rate for the categories of vascular AE (8.6% vs 3.0%) through 84 months. At 84 months, the adverse event rate between the Prestige LP™ PAS Cohort and the Control was statistically different with the 95% BCI for the difference of adverse events rates between the Prestige LP™ PAS Cohort and the ACDF Control Cohort being (4.2%,

13.9%), excluding 0. The conclusion of Bayesian analysis remains similar with the results of
time-to-event analyses.

120 Months The overall adverse event rate for subjects treated with the Prestige LP™ device was PAS Cohort, 98.2% and Safety Cohort, 98.2 through 120 months.

Regarding the vascular AE rates, more investigational subjects had Grade 3 or 4 vascular events
than control subjects (cumulative rate: 5.3% vs. 0.5%). However, none of these vascular events
was implant- or implant/surgical procedure-related according to the judgement determined by the
adjudication committee. Thirty-three vascular events were reported in the investigational group
for up to 120 months. Four of these events were surgical procedure-related and included bleeding
and excessive blood loss. These events are expected risks associated with any surgical procedure.
The remaining events were not related to the procedure nor the device. These events included
heterogenous pathologies such as occlusion, insufficiency, aneurysm, vascular leak, blood clots,
thrombosis, bleeding ulcer, vascular stenosis, and Raynaud’s disease. Case histories of those
events demonstrated various causes and/or risk factors such as trauma, hereditary disease,
hypertension, hypercholesterolemia, diabetes, gastrointestinal disorder, thyroid diseases,
arrhythmia, and cancer.

Prior to 24 months, two deaths occurred in the control group and none in the investigational
group. There were three deaths in the investigational group and five deaths in the control group
by 84 months. By 120 months, four deaths occurred in the investigational group. Deaths were
evaluated based upon available information and none of the deaths were believed to be in any
way related to the study treatment.

Medtronic Page 21 of 103

Mos)

Prestige LP™ Safety

Prestige LP™ Safety

ANATOMICAL/TECH
NICAL DIFFICULTY

2 (0.7) 2 0 (0.0) 0 2 (0.6)

2

2 (0.7) 2 0 (0.0) 0 2 (0.6)

2

0 (0.0) 0 0 (0.0) 0 0 (0.0)

0

3 (1.1) 5 2 (0.8) 2 5 (1.5)

7

15 (5.4)

22

18 (6.8)

20

26

0 (0.0) 0 3 (1.1) 3 0 (0.0)

0

DYSPHAGIA/
DYSPHONIA

26 (9.3)

31

22 (8.3)

24

29 (8.7)

35

21 (7.5)

23

22 (8.3)

24

23 (6.9)

26

8 (2.9) 8 0 (0.0) 0 9 (2.7)

9

33 (11.8)

55

39 (14.7)

69

42 (12.6)

69

HETEROTOPIC
OSSIFICATION

20 (7.1)

23

17 (6.4)

22

24 (7.2)

27

15 (5.4)

18

17 (6.4)

21

19 (5.7)

22

5 (1.8) 5 1 (0.4) 1 5 (1.5)

5

15 (5.4)

15

5 (1.9) 5 20 (6.0)

20

2 (0.7) 2 3 (1.1) 3 2 (0.6)

2

6 (2.1) 6 0 (0.0) 0 6 (1.8)

6

Displacement-

Subsidence

2 (0.7) 2 0 (0.0) 0 7 (2.1)

7

0 0 0 0 1 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0

0 (0.0)

2 (0.8)

0 (0.0)

Adverse Events

Total Adverse Events

Cervical-Study Surgery

Non-Cervical

CANCER
CARDIAC

DISORDERS
DEATH

Dysphagia

Dysphonia

GASTROINTESTINAL

Cervical

Non-Cervical

IMPLANT EVENTS

Breakage

Displacement

Loosening

14, 15

24 Months

(≥19 Mos- <30

ACDF Control

Prestige LP™ IDE Cohort

Surgery

Prestige LP™ IDE Cohort

Table 10a: Adverse Events in Pivotal Study Through 24 Months

Postoperative

(1 day - <4 Wks)

ACDF Control16

Prestige LP™ Safety Cohort

ACDF Control

Prestige LP™ IDE Cohort

6 Weeks

(≥4 Wks - <9 Wks)

Prestige LP™ IDE Cohort

Prestige LP™ Safety Cohort

3 Months

(≥9 Wks - <5 Mos)

Cohort

ACDF Control

ACDF Control

Prestige LP™ IDE Cohort

(≥5 Mos- <9 Mos)

Prestige LP™ Safety Cohort

6 Months

Prestige LP™ IDE Cohort

12 Months

(≥9 Mos- <19 Mos)

ACDF Control

Prestige LP™ Safety Cohort

ACDF Control

Prestige LP™ IDE Cohort

Prestige LP™ Safety Cohort

29 34 35 173 119 188 179 97 235 241 211 301 246 143 304 401 280 465 312 341 373

2 0 2 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0

2 0 2 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0

0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
0 0 0 1 1 1 0 0 0 0 0 0 1 0 1 3 0 3 0 1 2

0 0 0 2 2 2 2 1 4 0 2 0 2 3 2 5 3 6 11 9 12

0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 1 0 0 1 0
1 5 1 15 11 16 4 4 6 5 3 5 4 0 4 0 1 0 2 0 3

1 5 1 11 11 11 3 4 5 3 3 3 3 0 3 0 1 0 2 0 3

0 0 0 4 0 5 1 0 1 2 0 2 1 0 1 0 0 0 0 0 0

2 7 2 8 7 8 1 3 2 3 4 6 3 3 7 20 21 22 18 24 22
0 0 0 2 1 2 6 4 6 2 2 2 4 1 5 3 3 5 6 11 7

0 0 0 2 1 2 4 4 4 2 2 2 4 1 5 2 3 4 4 10 5

0 0 0 0 0 0 2 0 2 0 0 0 0 0 0 1 0 1 2 1 2

6 0 6 1 1 1 2 1 3 2 0 2 0 0 2 0 2 1 4 1 5
2 0 2 0 0 0 0 0 0 0 0 0 0 0 0 0 2 0 0 1 0

0 0 0 1 0 1 1 0 1 2 0 2 0 0 0 0 0 0 2 0 2

0 0 0 0 0 0 1 0 2 0 0 0 0 0 2 0 0 1 1 0 2

Total (Up to 24 Mos)

# of Patients Reporting & Total

adverse events

Cohort

Total # Events

#Patients (% of 280)

Prestige LP™ IDE Cohort

257 (91.8)

1581

219 (82.6)

ACDF Control

1225

Total # Events

#Patients (% of 265)

#Patients (% of 333)

Prestige LP™ Safety Cohort

307 (92.2)

1901

18 (5.4)

Total # Events

14

Based on 24-month cohort.

15

Some adverse events may lead to additional surgeries or interventions. Refer to Table 4 for more information.

16

Control=Single-level anterior interbody fusion procedure with allograft and plate stabilization. Non-randomized control arm from IDE study of Prestige™ Cervical Disc.

Medtronic Page 22 of 103

0 2 0

5 (1.8) 5 0 (0.0) 0 5 (1.5)

5

0 (0.0) 0 0 (0.0) 0 0 (0.0)

0

33 (11.8)

52

27 (10.2)

37

39 (11.7)

59

Deep Surgical Site

(Below Fasciae)-Cervical

0 (0.0) 0 1 (0.4) 1 0 (0.0)

0

31 (11.1)

46

22 (8.3)

30

35 (10.5)

50

0 (0.0) 0 1 (0.4) 1 1 (0.3)

1

Superfical Surgical Site

Cervical

0 (0.0) 0 0 (0.0) 0 0 (0.0)

0

3 (1.1) 3 1 (0.4) 1 5 (1.5)

5

NECK AND/OR ARM
PAIN

158 (56.4)

339

125 (47.2)

226

197 (59.2)

425

83 (29.6)

112

71 (26.8)

84

101 (30.3)

141

47 (16.8)

71

26 (9.8)

29

58 (17.4)

89

100 (35.7)

151

76 (28.7)

109

126 (37.8)

189

Neck Pain

(Non-Cervical)

5 (1.8) 5 4 (1.5) 4 6 (1.8)

6

114 (40.7)

199

106 (40.0)

219

134 (40.2)

238

20 (7.1)

20

11 (4.2)

13

26 (7.8)

26

4 (1.4) 4 5 (1.9) 6 4 (1.2)

4

6 (2.1) 6 6 (2.3) 6 6 (1.8)

6

Lower Extremity-

Sensory

14 (5.0)

18

20 (7.5)

27

15 (4.5)

20

43 (15.4)

51

30 (11.3)

40

50 (15.0)

59

0 (0.0) 0 0 (0.0) 0 0 (0.0)

0

Upper And Lower

Extremity-Motor

2 (0.7) 2 2 (0.8) 2 2 (0.6)

2

Upper And Lower

Extremity-Sensory

6 (2.1) 6 8 (3.0)

10

7 (2.1)

7

8 (2.9) 8 9 (3.4) 9 10 (3.0)

11

Upper Extremity-

61 (21.8)

84

67 (25.3)

106

73 (21.9)

103

1 (0.4) 1 33 (12.5)

34

1 (0.3)

1

91 (32.5)

174

82 (30.9)

131

111 (33.3)

208

142 (50.7)

274

129 (48.7)

225

170 (51.1)

325

37 (13.2)

44

34 (12.8)

37

46 (13.8)

55

Malpositioning

Other

INFECTION

Other Infection

Other Wound

(Skin To Fasciae)-

Systemic Infection

Urinary Tract Infection

Arm Pain (Cervical)

Arm Pain (Non-Cervical)

Neck Pain (Cervical)

NEUROLOGICAL

Carpal Tunnel Syndrome

Gait Disturbance

Lower Extremity-Motor

Non-Specific Or Other

Spinal Cord Disturbance

Upper Extremity-Motor

Sensory

NON-UNION

OTHER

OTHER PAIN

Back Pain

4 0 4 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 1
0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0

1 2 1 5 3 5 5 5 6 6 2 10 10 1 11 14 10 14 11 14 12

0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0

1 2 1 3 1 3 5 2 6 6 2 8 9 1 9 13 8 13 9 14 10
0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 1 0 0 0 0

0 0 0 1 1 1 0 3 0 0 0 0 1 0 1 0 0 0 1 0 1

0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0

0 0 0 1 1 1 0 0 0 0 0 2 0 0 0 1 0 1 1 0 1
3 2 4 35 18 37 54 19 76 70 49 90 52 42 66 76 55 92 49 41 60

2 1 3 15 9 16 13 9 22 22 22 27 20 10 24 26 18 31 14 15 18

0 0 0 2 2 2 12 2 16 15 6 20 14 4 17 12 10 16 16 5 18

1 1 1 17 7 18 29 8 38 32 21 42 18 25 25 36 27 42 18 20 23
0 0 0 1 0 1 0 0 0 1 0 1 0 3 0 2 0 3 1 1 1

2 6 2 14 24 16 23 18 29 36 36 42 24 17 31 69 57 81 31 61 37

0 0 0 1 1 1 1 3 1 3 1 4 5 1 6 8 3 10 2 4 4
0 0 0 0 0 0 0 0 0 0 0 0 0 2 0 3 4 3 1 0 1

0 0 0 1 0 1 0 0 0 0 0 0 2 2 2 3 1 3 0 3 0

1 0 1 3 2 4 1 1 1 1 10 2 3 1 3 5 4 5 4 9 4

1 2 1 4 6 4 6 7 7 3 5 5 6 4 8 22 7 24 9 9 10
0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0

0 0 0 0 0 0 0 0 0 1 0 1 0 0 0 0 2 0 1 0 1

0 0 0 0 0 0 1 1 1 1 5 1 0 1 0 3 2 3 1 1 2

0 2 0 0 2 0 1 0 2 4 0 4 1 1 1 1 3 3 1 1 1
0 2 0 5 13 6 13 6 17 23 15 25 7 5 11 24 31 30 12 34 14

0 0 0 0 0 0 0 3 0 0 4 0 1 9 1 0 9 0 0 9 0

4 3 7 19 14 22 14 13 15 23 17 27 29 10 39 56 20 62 29 54 36

4 6 4 19 19 20 33 10 38 48 44 64 53 28 65 69 58 77 48 60 57
0 1 0 0 1 0 7 1 9 11 11 16 12 8 13 10 6 13 4 9 4

3 (1.1)

3

4 (1.5)

4

3 (0.9)

3

Medtronic Page 23 of 103

53 (18.9)

65

36 (13.6)

40

66 (19.8)

80

10 (3.6)

10

7 (2.6) 7 12 (3.6)

12

102 (36.4)

155

92 (34.7)

141

121 (36.3)

178

24 (8.6)

34

17 (6.4)

23

27 (8.1)

39

93 (33.2)

195

58 (21.9)

114

119 (35.7)

240

Cervical-Non-Study

Surgery

44 (15.7)

71

31 (11.7)

58

57 (17.1)

93

27 (9.6)

36

12 (4.5)

15

33 (9.9)

42

45 (16.1)

88

27 (10.2)

41

54 (16.2)

105

65 (23.2)

76

35 (13.2)

44

75 (22.5)

88

26 (9.3)

40

9 (3.4)

11

32 (9.6)

46

12 (4.3)

13

3 (1.1) 3 13 (3.9)

14

3 (1.1) 3 1 (0.4) 1 4 (1.2)

4

9 (3.2)

10

2 (0.8) 2 9 (2.7)

10

WOUND (NON­INFECTIOUS)

21 (7.5)

31

13 (4.9)

13

22 (6.6)

32

1 (0.4) 1 1 (0.4) 1 1 (0.3)

1

5 (1.8) 5 1 (0.4) 1 5 (1.5)

5

6 (2.1) 6 3 (1.1) 3 6 (1.8)

6

12 (4.3)

19

8 (3.0) 8 13 (3.9)

20

Lower Extremity Pain

RESPIRATORY

SPINAL EVENT

Cervical-Study Surgery

Non-Cervical

TRAUMA

UROGENITAL

VASCULAR

Injury Intra-Operative

Dehiscence

Headache

Other

Other

Csf Leak

Hematoma

Other

1 2 1 5 3 5 12 3 14 11 7 13 8 2 12 18 11 22 10 12 13

0 0 0 1 0 1 1 1 1 0 2 1 2 1 3 4 0 4 2 3 2
3 3 3 13 15 14 13 5 14 26 24 34 31 17 37 37 41 38 32 36 38

0 0 0 8 4 8 0 4 1 1 1 1 11 5 11 1 1 4 13 8 14

0 0 0 22 8 26 25 6 38 26 30 32 26 15 32 52 22 61 44 33 51

0 0 0 10 3 11 13 3 20 11 12 14 9 7 14 13 11 18 15 22 16
0 0 0 9 2 9 9 1 10 3 6 4 5 0 5 5 1 6 5 5 8

0 0 0 3 3 6 3 2 8 12 12 14 12 8 13 34 10 37 24 6 27

0 0 0 6 2 8 5 4 6 13 12 14 12 5 13 20 9 23 20 12 24

1 0 1 1 0 1 2 0 2 1 1 1 8 3 8 11 5 12 16 2 21
3 1 4 1 0 1 1 0 1 1 1 1 2 0 2 0 1 0 5 0 5

3 1 4 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0

0 0 0 1 0 1 1 0 1 1 1 1 2 0 2 0 1 0 5 0 5

0 2 1 14 4 14 2 2 2 4 2 4 4 1 4 2 2 2 5 0 5
0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 1

0 0 0 3 1 3 0 0 0 0 0 0 0 0 0 1 0 1 1 0 1

0 0 0 2 3 2 1 0 1 1 0 1 0 0 0 1 0 1 1 0 1
0 1 1 9 0 9 1 2 1 3 2 3 4 1 4 0 2 0 2 0 2

Medtronic Page 24 of 103

Prestige LP™

Total # Events

Prestige LP™ Safety C

ANATOMICAL/

DIFFICULTY

2 (0.7) 2 0 (0.0) 0 2 (0.6) 2 2 (0.7)

2

2 (0.6)

2

1 (0.4) 1 0 (0.0) 0 1 (0.3) 1 1 (0.4)

1

1 (0.3)

1

6 (2.1)

12

5 (1.9) 5 9 (2.7)

15

10 (3.6)

21

14 (4.2)

27

61

46

74

94

107

2 (0.7) 2 5 (1.9) 5 3 (0.9) 3 3 (1.1)

3

4 (1.2)

4

DYSPHAGIA/
DYSPHONIA

31 (11.1)

37

26 (9.8)

31

36 (10.8)

44

33 (11.8)

40

38 (11.4)

47

25 (8.9)

27

26 (9.8)

30

28 (8.4)

32

26 (9.3)

29

29 (8.7)

34

10 (3.6)

10

1 (0.4) 1 12 (3.6)

12

11 (3.9)

11

13 (3.9)

13

64 (22.9)

140

64 (24.2)

120

80 (24.0)

176

74 (26.4)

190

93 (27.9)

241

HETEROTOPIC

44 (15.7)

52

34 (12.8)

44

56 (16.8)

65

50 (17.9)

65

68 (20.4)

89

37 (13.2)

42

31 (11.7)

36

45 (13.5)

51

39 (13.9)

47

53 (15.9)

63

10 (3.6)

10

7 (2.6) 8 14 (4.2)

14

16 (5.7)

18

22 (6.6)

26

20 (7.1)

22

9 (3.4)

11

27 (8.1)

29

24 (8.6)

28

31 (9.3)

35

3 (1.1) 4 5 (1.9) 5 3 (0.9) 4 4 (1.4)

5

4 (1.2)

5

6 (2.1) 6 0 (0.0) 0 6 (1.8) 6 7 (2.5)

7

7 (2.1)

7

Displacement-

Subsidence

6 (2.1) 6 1 (0.4) 1 12 (3.6)

12

7 (2.5)

7

13 (3.9)

13

0 (0.0) 0 4 (1.5) 5 0 (0.0) 0 0 (0.0)

0

0 (0.0)

0

Adverse Events

Total Adverse Events

TECHNICAL

Cervical-Study Surgery

Non-Cervical

CANCER
CARDIAC

DISORDERS
DEATH

Dysphagia

Dysphonia

GASTROINTESTINAL

OSSIFICATION

Cervical

Non-Cervical

IMPLANT EVENTS

Breakage

Displacement

Loosening

Table 10b: Adverse Events in Pivotal Study Through 120 Months

36 Months

(≥30 Mos - < 42 Mos)

ACDF Control

Prestige LP™ PAS Cohort

Prestige LP™ Safety Cohort

328 235 396 218 256 298 300 251 355 222 153 269 125 116 165

0 0 0 0 0 0 1 0 1 0 0 0 0 0 0

0 0 0 0 0 0 0 0 0 0 0 0 0 0 0

0 0 0 0 0 0 1 0 1 0 0 0 0 0 0

4 1 4 0 0 0 2 1 2 0 1 1 1 0 1

6 7 9 8 5 13 11 5 11 8 6 8 6 3 7

0 0 0 0 2 0 2 0 2 0 0 1 0 0 0

5 0 5 1 3 2 0 4 0 0 0 0 0 0 2

3 0 3 1 2 1 0 4 0 0 0 0 0 0 2
2 0 2 0 1 1 0 0 0 0 0 0 0 0 0

19 8 25 19 16 24 23 12 28 20 9 23 4 6 7

5 3 7 5 8 6 6 5 10 5 3 5 8 3 10

4 2 4 5 5 6 4 4 6 5 1 5 6 3 8
1 1 3 0 3 0 2 1 4 0 2 0 2 0 2

1 1 2 1 0 1 4 4 5 0 1 0 1 0 1

0 1 0 1 0 1 1 1 1 0 0 0 0 0 0

0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
1 0 2 0 0 0 2 1 2 0 0 0 1 0 1

0 0 0 0 0 0 0 2 0 0 1 0 0 0 0

48 Months

(≥42 Mos - < 54 Mos)

ACDF Control

Prestige LP™ PAS Cohort

(≥54 Mos - < 66 Mos)

Safety Cohort

Prestige LP™ PAS Cohort

60 Weeks

ACDF Control

(≥66 Mos - < 78 Mos)

Prestige LP™ Safety Cohort

72 Months

Prestige LP™ PAS Cohort

84 Months

(≥78 Mos - < 90 Mos)

ACDF Control

Prestige LP™ Safety Cohort

ACDF Control

Prestige LP™ PAS Cohort

Total (Up to 84 Months) # of Patients

Reporting & Total adverse events

Total # Events

ACDF Control

232 (87.5)

2236

0 (0.0)

37 (14.0)

Prestige LP™ Safety Cohort

#Patients (% of 280)

Prestige LP™ PAS Cohort

271 (96.8)

2774

3 (1.1)

3

39 (13.9)

#Patients (% of 265)

0

17, 18

Total # Events

#Patients (% of 333)

Prestige LP™ Safety Cohort

323 (97.0)

3384

3 (0.9)

3

47 (14.1)

Total (Up to 120 Months) # of Patients

Reporting & Total adverse events

Total # Events

#Patients (% of 280)

Prestige LP™ PAS Cohort

275 (98.2)

3523

3 (1.1)

3

Total # Events

ACDF Control

#Patients (% of 265)

-

-

-

-

-

49 (17.5)

-

-

-

-

-

-

-

-

-

-

-

-

-

-

ohort

#Patients (% of 333)

327 (98.2)

4276

3 (0.9)

3

57 (17.1)

Total # Events

17

Based on 24-month cohort.

18

Some adverse event s may lead to additional surgeries or interventions. Refer to Table 4 for more information.

Medtronic Page 25 of 103

6 (2.1) 6 0 (0.0) 0 6 (1.8) 6 6 (2.1)

7

6 (1.8)

7

0 (0.0) 0 0 (0.0) 0 1 (0.3) 1 2 (0.7)

2

3 (0.9)

3

61 (21.8)

117

49 (18.5)

78

72 (21.6)

141

75 (26.8)

156

89 (26.7)

193

Deep Surgical Site

Cervical

55 (19.6)

100

43 (16.2)

67

63 (18.9)

117

70 (25.0)

138

82 (24.6)

164

2 (0.7) 2 2 (0.8) 2 3 (0.9) 3 2 (0.7)

2

3 (0.9)

3

Superfical Surgical Site

Cervical

3 (1.1) 3 0 (0.0) 0 3 (0.9) 3 4 (1.4)

4

4 (1.2)

4

7 (2.5) 8 4 (1.5) 4 13 (3.9)

14

7 (2.5)

8

13 (3.9)

18

NECK AND/OR ARM
PAIN

186 (66.4)

483

156 (58.9)

342

231 (69.4)

598

195 (69.6)

548

241 (72.4)

678

109 (38.9)

162

88 (33.2)

122

136 (40.8)

205

115 (41.1)

173

144 (43.2)

220

Arm Pain (Non-

Cervical)

65 (23.2)

116

48 (18.1)

66

81 (24.3)

143

75 (26.8)

154

95 (28.5)

191

121 (43.2)

196

101 (38.1)

145

150 (45.0)

240

128 (45.7)

210

158 (47.4)

255

Neck Pain

(Non-Cervical)

8 (2.9) 9 9 (3.4) 9 9 (2.7)

10

9 (3.2)

11

10 (3.0)

12

147 (52.5)

290

144 (54.3)

348

172 (51.7)

346

164 (58.6)

352

191 (57.4)

414

27 (9.6)

28

18 (6.8)

20

34 (10.2)

35

32 (11.4)

36

39 (11.7)

43

4 (1.4) 4 6 (2.3) 7 4 (1.2) 4 5 (1.8)

5

5 (1.5)

5

9 (3.2)

9

13 (4.9)

13

10 (3.0)

10

10 (3.6)

12

12 (3.6)

14

Lower Extremity-

20 (7.1)

25

32 (12.1)

43

23 (6.9)

29

28 (10.0)

34

31 (9.3)

39

62 (22.1)

86

43 (16.2)

69

71 (21.3)

99

70 (25.0)

100

80 (24.0)

114

0 (0.0) 0 0 (0.0) 0 0 (0.0) 0 2 (0.7)

2

2 (0.6)

2

Upper And Lower

Extremity-Motor

2 (0.7) 2 2 (0.8) 2 2 (0.6) 2 2 (0.7)

2

2 (0.6)

2

Upper And Lower

Extremity-Sensory

9 (3.2)

9

11 (4.2)

13

11 (3.3)

11

9 (3.2)

9

12 (3.6)

12

12 (4.3)

12

14 (5.3)

14

15 (4.5)

16

14 (5.0)

14

17 (5.1)

18

Upper Extremity-

Sensory

79 (28.2)

115

95 (35.8)

167

94 (28.2)

140

88 (31.4)

138

104 (31.2)

165

2 (0.7)

3

35 (13.2)

38

2 (0.6) 3 6 (2.1)

7

6 (1.8)

7

142 (50.7)

367

123 (46.4)

275

174 (52.3)

440

160 (57.1)

510

195 (58.6)

604

181 (64.6)

486

167 (63.0)

418

221 (66.4)

596

196 (70.0)

609

237 (71.2)

742

61 (21.8)

73

54 (20.4)

62

75 (22.5)

91

73 (26.1)

88

89 (26.7)

108

Malpositioning

Other

INFECTION

(Below Fasciae)-

Other Infection

Other Wound

(Skin To Fasciae)-

Systemic Infection

Urinary Tract Infection

Arm Pain (Cervical)

Neck Pain (Cervical)

NEUROLOGICAL

Carpal Tunnel Syndrome

Gait Disturbance

Lower Extremity-Motor

Sensory

Non-Specific Or Other

Spinal Cord Disturbance

Upper Extremity-Motor

NON-UNION

OTHER

OTHER PAIN

Back Pain

0 0 0 0 0 0 1 0 1 0 0 0 0 0 0

0 0 0 0 0 0 0 0 1 0 0 0 0 0 0

18 10 23 6 6 13 23 4 23 9 10 14 9 11 9

0 0 0 0 0 0 0 0 0 0 0 0 0 0 0

13 10 17 5 4 10 20 4 20 9 10 13 7 9 7

2 0 2 0 0 0 0 0 0 0 0 0 0 1 0

0 0 0 1 0 1 0 0 0 0 0 0 0 0 0

0 0 0 0 0 0 2 0 2 0 0 0 1 0 1

3 0 4 0 2 2 1 0 1 0 0 1 1 1 1
39 28 46 25 36 34 37 23 42 29 5 31 14 24 20

18 7 20 8 8 14 10 6 10 8 2 9 6 15 11

10 8 13 9 14 11 12 12 15 11 1 11 3 2 4

11 11 13 7 11 8 12 5 14 10 2 11 5 7 5

0 2 0 1 3 1 3 0 3 0 0 0 0 0 0

25 42 30 15 28 19 20 30 22 23 11 26 8 18 11

4 2 4 1 2 1 1 1 1 2 1 3 0 1 0

0 1 0 0 0 0 0 0 0 0 0 0 0 0 0

2 1 2 1 2 2 0 2 0 0 0 0 0 2 0

2 10 2 1 3 2 3 3 4 0 0 0 1 0 1

8 13 9 6 9 7 10 2 11 10 4 11 1 1 2

0 0 0 0 0 0 0 0 0 0 0 0 0 0 0

0 0 0 0 0 0 0 0 0 0 0 0 0 0 0

1 0 1 1 2 1 0 1 0 1 0 2 0 0 0

1 2 1 0 1 0 1 0 1 1 1 1 1 1 2

7 13 11 5 9 6 5 21 5 9 5 9 5 13 6

0 1 0 1 0 1 1 2 1 0 0 0 0 1 0

40 26 45 38 31 48 45 43 54 45 31 53 25 13 32

64 49 80 50 45 66 52 50 65 25 30 29 21 19 31

9 6 11 8 8 9 5 5 7 2 2 3 5 4 6

0 (0.0)

0

4 (1.4)

4

1 (0.4)

1

4 (1.5)

4

0 (0.0)

0

4 (1.2)

4

0 (0.0)

0

4 (1.4)

4

-

-

-

0 (0.0)

-

0

-

-

4 (1.2)

-

4

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

Medtronic Page 26 of 103

66 (23.6)

92

54 (20.4)

66

79 (23.7)

108

68 (24.3)

102

83 (24.9)

122

24 (8.6)

26

16 (6.0)

17

27 (8.1)

29

32 (11.4)

39

36 (10.8)

43

139 (49.6)

295

135 (50.9)

273

171 (51.4)

368

156 (55.7)

380

189 (56.8)

469

46 (16.4)

68

32 (12.1)

50

55 (16.5)

81

57 (20.4)

95

69 (20.7)

111

127 (45.4)

341

106 (40.0)

242

161 (48.3)

429

149 (53.2)

447

186 (55.9)

558

Cervical-Non-Study

Surgery

69 (24.6)

133

64 (24.2)

112

88 (26.4)

165

88 (31.4)

179

108 (32.4)

214

43 (15.4)

59

18 (6.8)

25

51 (15.3)

68

54 (19.3)

73

64 (19.2)

84

73 (26.1)

149

55 (20.8)

105

91 (27.3)

196

83 (29.6)

195

106 (31.8)

260

106 (37.9)

143

79 (29.8)

116

125 (37.5)

173

121 (43.2)

178

142 (42.6)

214

51 (18.2)

83

26 (9.8)

41

61 (18.3)

100

58 (20.7)

110

70 (21.0)

130

24 (8.6)

30

8 (3.0) 8 26 (7.8)

32

26 (9.3)

33

29 (8.7)

36

3 (1.1) 3 1 (0.4) 1 4 (1.2) 4 3 (1.1)

3

4 (1.2)

4

21 (7.5)

27

7 (2.6) 7 22 (6.6)

28

23 (8.2)

30

25 (7.5)

32

WOUND (NON­INFECTIOUS)

23 (8.2)

34

18 (6.8)

18

25 (7.5)

36

23 (8.2)

34

25 (7.5)

36

1 (0.4) 1 1 (0.4) 1 1 (0.3) 1 1 (0.4)

1

1 (0.3)

1

5 (1.8) 5 1 (0.4) 1 5 (1.5) 5 5 (1.8)

5

5 (1.5)

5

6 (2.1) 6 4 (1.5) 4 6 (1.8) 6 6 (2.1)

6

6 (1.8)

6

14 (5.0)

22

12 (4.5)

12

16 (4.8)

24

14 (5.0)

22

16 (4.8)

24

Lower Extremity Pain

RESPIRATORY

SPINAL EVENT

Cervical-Study Surgery

TRAUMA

UROGENITAL

VASCULAR

Injury Intra-Operative

Headache

Other

Non-Cervical

Other

Csf Leak

Dehiscence

Hematoma

Other

9 9 9 6 3 6 8 5 9 2 5 2 2 4 2

6 3 6 1 3 1 3 4 4 4 0 4 2 0 2
40 31 54 35 31 50 36 36 45 17 23 20 12 11 21

3 4 6 1 2 3 13 10 14 12 8 14 5 3 5

68 31 76 16 47 26 25 30 37 24 14 34 13 6 16

28 14 29 7 21 13 12 9 13 11 5 11 4 5 6

9 2 9 3 2 4 4 3 6 3 2 3 4 1 4

31 15 38 6 24 9 9 18 18 10 7 20 5 0 6

18 15 21 14 20 21 15 15 18 11 15 14 9 7 11

7 6 11 14 5 16 14 11 14 7 7 11 1 1 2

4 1 4 4 2 5 5 1 5 4 1 4 0 0 0

0 0 0 0 0 0 0 0 0 0 0 0 0 0 0

4 1 4 4 2 5 5 1 5 4 1 4 0 0 0

2 2 2 0 0 0 1 1 1 0 1 1 0 1 0

0 0 0 0 0 0 0 0 0 0 0 0 0 0 0

0 0 0 0 0 0 0 0 0 0 0 0 0 0 0

0 0 0 0 0 0 0 0 0 0 0 0 0 1 0

2 2 2 0 0 0 1 1 1 0 1 1 0 0 0

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

Medtronic Page 27 of 103

Prestige LP™ IDE Cohort

(N=280)

ACDF Control

(N=265)

Prestige LP™ Safety Cohort

(N=333)

Dysphagia / Dysphonia

0

0 (0.0)

1

1 (0.4)

0

0 (0.0)

Heterotopic Ossification

2

2 (0.7)

5

4 (1.5)

3

3 (0.9)

Implant Events

14

14 (5.0)

5

5 (1.9)

17

17 (5.1)

Neck and / or Arm Pain

1

1 (0.4)

0

0 (0.0)

1

1 (0.3)

Neurological

12

8 (2.9)

9

6 (2.3)

16

10 (3.0)

Non-Union

11

8 (2.9)

8

8 (3.0)

12

9 (2.7)

Other 1 1 (0.4)

28

28 (10.6)

1

1 (0.3)

Other Pain 0 0 (0.0)

1

1 (0.4)

0

0 (0.0)

Spinal Event

4

4 (1.4)

7

4 (1.5)

4

4 (1.2)

Trauma

20

14 (5.0)

8

5 (1.9)

21

15 (4.5)

Wound (Non-Infectious)

1

1 (0.4)

0

0 (0.0) 1 1 (0.3)

Any Adverse Event

0

0 (0.0) 1 1 (0.4)

0

0 (0.0)

Prestige LP™ PAS Cohort

(N=280)

ACDF Control

(N=265)

Prestige LP™ Safety Cohort

(N=333)

Dysphagia / Dysphonia

0

0 (0.0)

1

1 (0.4)

0

0 (0.0)

Heterotopic Ossification

13

12 (4.3)

5

4 (1.5)

18

17 (5.1)

Implant Events

19

19 (6.8)

10

8 (3.0)

23

23 (6.9)

Infection 1 1 (0.4)

0

0 (0.0)

1

1 (0.3)

Neck and / or Arm Pain

13

9 (3.2)

11

8 (3.0)

17

11 (3.3)

Neurological

11

8 (2.9)

8

8 (3.0)

12

9 (2.7)

Non-Union

1

1 (0.4)

32

30 (11.3)

1

1 (0.3)

Other 0 0 (0.0)

1

1 (0.4)

0

0 (0.0)

Other Pain 4 4 (1.4)

7

4 (1.5)

4

4 (1.2)

Spinal Event

36

20 (7.1)

9

6 (2.3)

37

21 (6.3)

Trauma 1 1 (0.4)

1

1 (0.4)

1

1 (0.3)

Wound (Non-Infectious)

0

0 (0.0)

1

1 (0.4)

0

0 (0.0)

Any Adverse Event

99

49 (17.5)

86

44 (16.6)

114

61 (18.3)

Table 10c: Adverse Events Classified as Device-Related or Device/Surgical Procedure-

Related According to the Clinical Adjudication Committee through Month 24 – Safety

Population

Device Relationship of
Adverse Event
Determined by CAC

Events

N

Patients

N (%)

Events

N

Patients

N (%)

Events

N

Patients

N (%)

Table 10d: Adverse Events Classified as Device-Related or Device/Surgical Procedure­Related According to the Clinical Adjudication Committee through Month 84 – Safety

Population

Device Relationship of
Adverse Event
Determined by CAC

Events

N

Patients

N (%)

Events

N

Patients

N (%)

Events

N

Patients

N (%)

Medtronic Page 28 of 103

Prestige LP™ PAS Cohort

(N=280)

ACDF Control

(N=265)

Prestige LP™ Safety Cohort

(N=333)

Dysphagia / Dysphonia

0

0 (0.0) - - 0 0 (0.0)

Heterotopic Ossification

15

14 (5.0) - -

24

23 (6.9)

Implant Events

23

21 (7.5) - -

27

25 (7.5)

Infection 1 1 (0.4) - -

1

1 (0.3)

Neck and / or Arm Pain

14

10 (3.6) - -

18

12 (3.6)

Neurological

12

9 (3.2) - -

13

10 (3.0)

Non-Union

1

1 (0.4) - -

1

1 (0.3)

Other 0 0 (0.0) - - 0 0 (0.0)

Other Pain 4 4 (1.4) - - 4 4 (1.2)

Spinal Event

43

26 (9.3) - -

46

29 (8.7)

Trauma 1 1 (0.4) - - 1 1 (0.3)

Wound (Non-Infectious)

0

0 (0.0) - - 0 0 (0.0)

Any Adverse Event

114

56 (20.1) - -

135

73 (21.9)

Adverse Event

Definition

Anatomical/Technical Difficulty

region other than the cervical spine

Cancer

A malignancy or malignant tumor/neoplasm

Cardiac Disorders

Any condition of the heart

Death

Termination of life due to any cause

Dysphagia/Dysphonia

• Dysphonia

• Difficulty in speaking

Gastrointestinal

Any conditi o n pe r taining to the stomach or intestines

Heterotopic Ossification

other region of the body

Implant Events

implant displa cement, implan t lo osening, or imp la nt br e a k i ng

Infection

Neck and/or Arm Pain

are such that ce rvical spine etiology cannot be ruled ou t

Table 10e: Adverse Events Classified as Device-Related or Device/Surgical Procedure-

Related According to the Clinical Adjudication Committee through Month 120 – Safety

Population

Device Relationship of
Adverse Event
Determined by CAC

Events

N

Patients

N (%)

Events

N

Patients

N (%)

Events

N

Patients

N (%)

Table 11: Adverse Event Categories

• Cer v ical Study Surgery

• Non-Cervical

• Dysphagia

• Heterotopic Ossification-Cervical

• Heterotopic Ossification-Non-Cervical

• Implant Events-Breakage

• Implant Events-Displacement

• Implant Events-Displace-Subsidence

• Implant Events-Loosening

• Implant Events-Malpositioning

• Implant Events-Other

• Deep Surgical Site (Below Fasciae)

Cervical

• Oth er Wound
Infection- Non-Surgical/Non-Study Site

• Superficial Surgical Site (skin to fascia)

Cervical

• Systemic

• Urinary Tract

• Other Infection

• Anatomical or tech nical difficulty encountered durin g the original im plantatio n of the

Prestige LP™ device or contr ol tr eatment device occurring at the level of t he s t udy surgery

• Anatomical or tech nical difficulty encountered durin g an additiona l s urgery that in v olved a

• Difficulty in swallowing

• Event involving heterotopic ossification at any region of the cervical spine

• Event involving heterotopic ossification at any region of the spine that is not cervical or any

• Breakage of any impl ant or implant com ponent

• Incomplete or partial dislocation of the impl ant

• Event associated with implant subsidence into the vertebral body when the reported term

includes “subsiden ce”

• Wear around the implant and/or loosening of the implant surface

• Poor or inappropria t e pl a cement of the im pl ant

• Event that is implant-rela ted, but does not meet th e def i n ition of malpos itioned imp lant,

• Infection below the fascia at the surgical incision

• Infection occurring in other surgical wound not involving the study

• Infection near the surface of the surgical incision

• Infection pertaining to the whole body

• Infection of any part of the urinary system

• Any infection not listed above

• Neck Pain (Cervical)

Medtronic Page 29 of 103

• Pain involving the neck region, which does not include neurological systems. The symptoms

• Neck Pain (Non-Cervical)

• Pain involving the neck which does not include neck neurological symptoms. Information is

available at the reported event time to reasonably ru le out cervic al spine etiology

Neurological

extremity and may be radiating, continuing, extending, or spreading to an adjacent anatomy

Non-Union

Failure of vertebral bodies to fuse

Other

Event not associated with any other categories (e.g., weight loss, tinnitus, substance abuse,
insomnia)

Other Pain

extremity pain (e.g., earache, fibromyalgia, non-cardiac chest pain , s ore throat, arthritis)

Respiratory

Ailments or symptoms associated with respiration or the respiratory system

Spinal Event

confirmed via radiologic findings

Trauma

Physical injury caused by a physical force or traumatic event (e.g., motor vehicle accident, fall,
etc.)

Urogenital

Any condition, relating to, affecting, treating, or being the organs or functions of excretion and
reproduction

Vascular

• Vascular-Other

• Disorder or condition in which the vascu lar system is affected

Wound (Non-Infectious)

oozing, scar tissue, incisional edemas, scratches to the skin surface)

• Arm Pain (Cervical)

• Arm Pain (Non-Cervical)

• Carpal Tunnel Syndrome

• Gait Disturbance

• Lower Extremity-Motor

• Lower Extremity-Sensory

• Non-Specific or Other

• Spine Cord Disturbance

• Upper Extremity-Motor

• Upper Extremity-Sensory

• Upper & Lower Extremity-Motor

• Upper & Lower Extremity-Sensory

availabl e at the reported event time to r easonably r ule out cervical spine etiology

• Pain involving the arm, which does not include neurological symptoms. These symptoms

are such that a cervical spine etiology cannot be ruled out

• Pain involving the arm which does not include neck neurological symptoms. Information is

• Event that is descri bes a s C ar pal Tunnel S yn drome or CTS

• Neurological condition in which the ga it is affected

• Event that involves a feeling or awareness of condition wit hin the body resulting fro m

stimulation of motor neur ons that ind uce movements, as nerves or m us cles. Such m o ve ments
would affect any part of the lower extremity including the hip, thigh, calf, foot, or toes and
may be muscular in na t ur e

• Event that involves a feeling or awareness of condition within the body resulting from

stimulation of sensory receptors. Such sensation would affect any part of the lower extremity
including t he h ip, thigh, calf , foot, or toes a nd may be radiating, continuing, extending, or
spreading to an adjacent anatomy

• Neurological even t n ot a ssociated with any other neurologic al categories or are neurol ogical

in nature but n ot specific eno u gh to fit into othe r s u bcategories

• Condition in which there is a dis ruption or dis t urbance to the s pi nal cord

• Event that involves stimulation of the motor neurons that induce movements, as nerves or

muscles. Such events would affect any part of the upper extremity including the shoulder,
brachium, elbow, forearm, hand, and fingers and may be muscular in nature

• Event that involves a feeling or awareness of condition within the body resulting from

stimulation of sensory receptors. Such sensation would affect any part of the upper extremity
including t he s h ou lder, brachium, elbow, forearm, hand, and fingers and may be radiating,
continuing, extending, or spreading to an adjacent anatomy

• Event that involves a feeling or awareness of condition within the body resulting from

stimulation of motor neur ons that ind uce movements , as ner v es or muscles. Such events
would affect any part of the upper or lower extremity and may be muscular in nature

• Event that involves a feeling or awareness of condition within the body resulting from

stimulation of sensory receptors. Such sensation would affect any part of the upper or lower

• Back Pain

• Headache

• Lower Extremity Pain

• Other

• Spinal Event-Cervical Study Surgery

• Spinal Event-Cervical Non-Study Surgery

• Spinal Event-Non-Cervical

• Vascular-Injury (intra-operative)

• Wound (Non-Infectious)- CSF Leak

• Wound (Non-Infectious)-Dehiscence

• Wound (Non-Infectious)-Hematoma

• Wound (Non-Infectious)-Other

Medtronic Page 30 of 103

• Pain (including stiffness, strain, tightness) in an area that is not of the cervical spine region,

occurring in th e back (e.g., low back pain, th or acic back pain , back pain)

• Pain occurring in the head (e.g., headache, migraine headache, head pain)

• Pain occurring in the lower extremity and using the term “pain” (e.g., leg pain, knee pain,

calf pain, foot pain)

• Pain occurring in parts of the body that ar e not cl as sif i ed as headache, back pain, or lower

• Event involving cervical spine diagnoses at the study treatment level; usually confirmed via

radiologic findings

• Event involving cervical spine diagno s es at on e or m ore cervical spine level ( s) , exce pt for th e

treated level; usually confirmed via radiographic findings

• Event involving diagnoses at one or more spine levels other than cervical spine; usually

• Injury to a vascular structure that is sustained during the course of the operative procedure;

initial study surgery only

• Compromise or tear of the dura mater resulting in leakage of cerebral spinal fluid, excluding

infection. Fluid is clear and free of microorganisms

• A bursting open or separation of a wound without the presence of microorganisms

• Swelling or mass of bl oo d (usually cl otted) confin ed to an organ, tis s u e , or s pace and cause d

by a break in a blo o d vessel. Wound is not limited to a specific anatomic region and there is
an absence of microorganisms

• Wound condition in which there is an absence of infection or other feature (e.g., wound