Medtronic G7002526 Instructions for Use

VERTEX® Reconstruction System M708348B445E Rev. B

2015-12-03

IMPORTANT INFORMATION ON THE VERTEX® RECONSTRUCTION SYSTEM

PURPOSE

The VERTEX® Reconstruction System is intended to help provide immobilization and stabilization of spinal segments as an
adjunct to fusion of the craniocervical, cervical, and/or upper thoracic spine (occiput-T3).

DESCRIPTION

The VERTEX® Reconstruction System is a posterior system, which consists of a variety of shapes and sizes of plates, rods,
hooks, screws, multi-axial screws, and connecting components, which can be rigidly locked to the rod in a variety of
configurations, with each construct being tailor-made for the individual case. Titanium ATLAS™ cable may be used with this
system at the surgeon’s discretion. See the package inserts of both of those systems for labeling limitations.

The VERTEX
grade cobalt chromium. Medical grade titanium, medical grade titanium alloy, and/or medical grade cobalt chromium may be
used together. Never use titanium, titanium alloy, and/or cobalt chromium with stainless steel in the same construct. The

VERTEX
NiTi). Shape Memory Alloy is compatible with titanium, titanium alloy, and cobalt chromium implants only. The posted screw
connectors and some multi-axial screws contain elastomeric stakes made of silicone adhesive commonly used in implantable
medical devices. Do not use with stainless steel. No warranties, express or implied, are made. Implied warranties of
merchantability and fitness for a particular purpose or use are specifically excluded.

To achieve best results, do not use any of the VERTEX
any other system or manufacturer unless specifically labeled to do so in this or another Medtronic document. As with all

orthopedic and neurosurgical implants, none of the VERTEX
any circumstances.

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Reconstruction System is fabricated from medical grade titanium, medical grade titanium alloy, and medical

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Reconstruction System includes a retaining ring for the multi-axial screw made of Shape Memory Alloy (Nitinol –

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Reconstruction System implant components with components from

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Reconstruction System components should ever be reused under

INDICATIONS

The VERTEX® Reconstruction System is intended to provide immobilization and stabilization of spinal segments as an adjunct
to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the
thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous
fusions (e.g., pseudarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy
and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease

of the facets with instability. The VERTEX
even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in
whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, the VERTEX
Spinal System rods with the VERTEX® rod connectors. Transition rods with differing diameters may also be used to connect the
VERTEX® Reconstruction System to the CD HORIZON
insert for a list of the CD HORIZON

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Reconstruction System is also intended to restore the integrity of the spinal column

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Reconstruction System may be connected to the CD HORIZON

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Spinal System indications of use.

Spinal System. Refer to the CD HORIZON® Spinal System package

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CONTRAINDICATIONS

Contraindications include, but are not limited to:

▪ Active infectious process or significant risk of infection (immunocompromise).
▪ Signs of local inflammation.
▪ Fever or leukocytosis.
▪ Morbid obesity.
▪ Pregnancy.
▪ Mental illness.
▪ Grossly distorted anatomy caused by congenital abnormalities.
▪ Any other medical or surgical condition which would preclude the potential benefit of spinal implant surgery, such as the

presence of congenital abnormalities, elevation of sedimentation rate unexplained by other diseases, elevation of white
blood count (WBC), or a marked left shift in the WBC differential count.

▪ Suspected or documented metal allergy or intolerance.
▪ Any case not needing a bone graft and fusion.
▪ Any case where the implant components selected for use would be too large or too small to achieve a successful result.
▪ Any patient having inadequate tissue coverage over the operative site or inadequate bone stock or quality.
▪ Any patient in which implant utilization would interfere with anatomical structures or expected physiological performance.
▪ Any patient unwilling to follow postoperative instructions.
▪ Any case not described in the indications.

NOTA BENE: Although not absolute contraindications, conditions to be considered as potential factors for not using
this device include:

▪ Severe bone resorption.
▪ Osteomalacia.
▪ Severe osteoporosis.

POTENTIAL ADVERSE EVENTS

All of the possible adverse events associated with spinal fusion surgery without instrumentation are possible. With
instrumentation, a listing of potential adverse events includes, but is not limited to:

▪ Early or late loosening of any or all of the components.
▪ Disassembly, bending, and/or breakage of any or all of the components.
▪ Foreign body (allergic) reaction to implants, debris, corrosion products (from crevice, fretting, and/or general corrosion),

including metallosis, staining, tumor formation, and/or autoimmune disease.

▪ Pressure on the skin from component parts in patients with inadequate tissue coverage over the implant possibly causing

skin penetration, irritation, fibrosis, necrosis, and/or pain.

▪ Bursitis.
▪ Tissue or nerve damage caused by improper positioning and placement of implants or instruments.
▪ Post-operative change in spinal curvature, loss of correction, height, and/or reduction.
▪ Infection.
▪ Dural tears, pseudomeningocele, fistula, persistent CSF leakage, meningitis.
▪ Loss of neurological function (e.g., sensory and/or motor), including paralysis (complete or incomplete), dysesthesias,

hyperesthesia, anesthesia, paresthesia, appearance of radiculopathy, and/or the development or continuation of pain,
numbness, neuroma, spasms, sensory loss, tingling sensation, and/or visual deficits.

▪ Neuropathy, neurological deficits (transient or permanent), paraplegia, paraparesis, reflex deficits, irritation, arachnoiditis,

and/or muscle loss.

▪ Urinary retention or loss of bladder control or other types of urological system compromise.
▪ Scar formation possibly causing neurological compromise or compression around nerves and/or pain.
▪ Fracture, microfracture, resorption, damage, or penetration of any spinal bone (including the sacrum, pedicles, and/or

vertebral body), and/or bone graft or bone graft harvest site at, above, and/or below the level of surgery.

▪ Retropulsed graft.
▪ Herniated nucleus pulposus, disc disruption or degeneration at, above, or below the level of surgery.
▪ Non-union (or pseudarthrosis), delayed union, or mal-union.
▪ Loss of or increase in spinal mobility or function.
▪ Inability to perform the activities of daily living.
▪ Bone loss or decrease in bone density, possibly caused by stresses shielding.
▪ Graft donor site complications including pain, fracture, or wound healing problems.
▪ Ileus, gastritis, bowel obstruction or loss of bowel control or other types of gastrointestinal system compromise.
▪ Hemorrhage, hematoma, occlusion, seroma, edema, hypertension, embolism, stroke, excessive bleeding, phlebitis, wound

necrosis, wound dehiscence, damage to blood vessels, or other types of cardiovascular system compromise.

▪ Reproductive system compromise, including sterility, loss of consortium, and sexual dysfunction.
▪ Development of respiratory problems (e.g., pulmonary embolism, atelectasis, bronchitis, pneumonia, etc.).
▪ Change in mental status.
▪ Death.

Note: Additional surgery may be necessary to correct some of these potential adverse events.

WARNINGS AND PRECAUTIONS

A successful result is not always achieved in every surgical case. This fact is especially true in spinal surgery where many
extenuating circumstances may compromise the results. This device system is not intended to be the sole means of spinal
support. Use of this product without a bone graft or in cases that develop into a non-union will not be successful. No spinal
implant can withstand body loads without the support of bone. In this event, bending, loosening, disassembly, and/or breakage
of the device(s) will eventually occur.

Preoperative and operating procedures, including knowledge of surgical techniques, good reduction, and proper selection and
placement of the implants are important considerations in the successful utilization of the system by the surgeon. Further, the
proper selection and compliance of the patient will greatly affect the results. Patients who smoke have been shown to have an
increased incidence of non-unions. These patients should be advised of this fact and warned of this consequence. Obese,

malnourished, and/or alcohol abuse patients are also poor candidates for spine fusion. Patients with poor muscle and bone
quality and/or nerve paralysis are also poor candidates for spine fusion.

Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with
significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical
instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the
L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation,
scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis). The safety and effectiveness of these devices for
any other conditions are unknown.

Precaution: The implantation of spinal screw systems should be performed only by experienced spinal surgeons with specific
training in the use of this spinal screw system because this is a technically demanding procedure presenting a risk of serious
injury to the patient.

This system was designed for single patient use only. Never, under any circumstances, reuse a VERTEX® Reconstruction
System device. Even when a removed device appears undamaged, it may have small defects or internal stress patterns that
may lead to early breakage.

This system was designed for single patient use only. Never, under any circumstances, reuse a VERTEX® Reconstruction
System device. Even when a removed device appears undamaged, it may have small defects or internal stress patterns that
may lead to early breakage.

Precaution: The implantation of spinal fixation systems should be performed only by experienced spinal surgeons with specific
training in the use of these spinal systems because this is a technically demanding procedure presenting a risk of serious injury
to the patient. Preoperative planning and patient anatomy should be considered when selecting implant diameter and length.

Precaution: Pre-Operative Planning - Use of cross sectional imaging (i.e., CT and/or MRI) for posterior cervical screw
placement is recommended due to the unique risks in the cervical spine. The use of planar radiographs alone may not provide
the necessary imaging to mitigate the risk of improper screw placement. In addition, use of intraoperative imaging should be
considered to guide and/or verify device placement, as necessary.

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.

FOR US AUDIENCES ONLY

CAUTION: FEDERAL LAW (USA) RESTRICTS THESE DEVICES TO SALE BY OR ON THE ORDER
OF A PHYSICIAN.

IMPLANT SELECTION

The selection of the proper size, shape, and design of the implant for each patient is crucial to the success of the procedure.
Metallic surgical implants are subject to repeated stresses in use, and their strength is limited by the need to adapt the design to
the size and shape of human bones. Unless great care is taken in patient selection, proper placement of the implant, and
postoperative management to minimize stresses on the implant, such stresses may cause metal fatigue and consequent
breakage, bending or loosening of the device before the healing process is complete, which may result in further injury or the
need to remove the device prematurely.

PREOPERATIVE

▪ Only patients that meet the criteria described in the indications should be selected.
▪ Patient conditions and/or pre-dispositions such as those addressed in the aforementioned contraindications should be

avoided.

▪ Care should be used in the handling and storage of the implant components. The implants should not be scratched or

otherwise damaged. Implants and instruments should be protected during storage especially from corrosive environments.

▪ An adequate inventory of implants should be available at the time of surgery, normally a quantity in excess of what is

expected to be used.

▪ Since mechanical parts are involved, the surgeon should be familiar with the various components before using the

equipment and should personally assemble the devices to verify all parts and necessary instruments are present before the
surgery begins. The VERTEX

combined with the components from another manufacturer. Different metal types should never be used together.

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Reconstruction System components (described in the DESCRIPTION section) are not to be

▪ All components and instruments should be cleaned and sterilized before use. Additional sterile components should be

available in case of an unexpected need.

INTRAOPERATIVE

▪ Extreme caution should be used around the spinal cord and nerve roots. Damage to the nerves will cause loss of

neurological functions.

▪ Breakage, slippage, or misuse of instruments or implant components may cause injury to the patient or operative personnel.
▪ The rods should not be repeatedly or excessively bent. The rods should not be reverse bent in the same location. Use great

care to ensure the implant surfaces are not scratched or notched, since such actions may reduce the functional strength of
the construct. If the rods are cut to length, they should be cut in such a way as to create a flat, non-sharp surface
perpendicular to the midline of the rod. Cut the rods outside the operative field. Whenever possible, use pre-cut rods of the
length needed.

▪ Whenever possible or necessary, an imaging system should be utilized to facilitate surgery.

▪ To insert a screw properly, drill a pilot hole corresponding to selected screw size and prepare screw site.
▪ Caution: Do not overtap or use a screw that is either too long or too large. Overtapping or using an incorrectly sized screw

may cause nerve damage, hemorrhage, or the other possible adverse events listed elsewhere in this package insert.

▪ Bone graft must be placed in the area to be fused and graft material must extend from the upper to the lower vertebrae

being fused.

▪ Before closing the soft tissues, all screws or set screws should be tightened firmly. Recheck the tightness of all screws or

set screws after finishing to make sure none loosened during the tightening of the other screws or set screws. Failure to do
so may cause loosening of other components.

POSTOPERATIVE

The physician's postoperative directions and warnings to the patient, and the corresponding patient compliance, are extremely
important.

▪ Detailed instructions on the use and limitations of the device should be given to the patient. If partial weight-bearing is

recommended or required prior to firm bony union, the patient must be warned that bending, loosening, and/or breakage of
the device(s) are complications which may occur as a result of excessive or early weight-bearing or muscular activity. The
risk of bending, loosening, or breakage of a temporary internal fixation device during postoperative rehabilitation may be
increased if the patient is active, or if the patient is debilitated or demented. The patient should be warned to avoid falls or
sudden jolts in spinal position.

▪ To allow the maximum chances for a successful surgical result, the patient or devices should not be exposed to mechanical

vibrations or shock that may loosen the device construct. The patient should be warned of this possibility and instructed to
limit and restrict physical activities, especially lifting and twisting motions and any type of sport participation. The patient
should be advised not to smoke tobacco or utilize nicotine products, or to consume alcohol or non-steroidals or anti­inflammatory medications such as aspirin during the bone graft healing process.

▪ The patient should be advised of their inability to bend or rotate at the point of spinal fusion and taught to compensate for

this permanent physical restriction in body motion.

▪ Failure to immobilize a delayed or non-union of bone will result in excessive and repeated stresses on the implant. By the

mechanism of fatigue, these stresses can cause the eventual bending, loosening, or breakage of the device(s). It is
important that immobilization of the spinal surgical site be maintained until firm bony union is established and confirmed by
roentgenographic examination. If a state of non-union persists or if the components loosen, bend, and/or break, the
device(s) should be revised and/or removed immediately before serious injury occurs. The patient must be adequately
warned of these hazards and closely supervised to ensure cooperation until bony union is confirmed.

▪ As a precaution, before patients with implants receive any subsequent surgery (such as dental procedures), prophylactic

antibiotics may be considered, especially for high-risk patients.

▪ The VERTEX

designed to stabilize the operative site during the normal healing process. After the spine is fused, these devices serve no
functional purpose and should be removed. While the final decision on implant removal is, of course, up to the surgeon and
patient, in most patients, removal is indicated because the implants are not intended to transfer or support forces developed
during normal activities. If the device is not removed following completion of its intended use, one or more of the following
complications may occur: (1) Corrosion, with localized tissue reaction or pain; (2) Migration of implant position, possibly
resulting in injury; (3) Risk of additional injury from postoperative trauma; (4) Bending, loosening, and breakage, which
could make removal impractical or difficult; (5) Pain, discomfort, or abnormal sensations due to the presence of the device;
(6) Possible increased risk of infection; (7) Bone loss due to stress shielding; and (8) Potential unknown and/or unexpected
long term effects such as carcinogenesis. Implant removal should be followed by adequate postoperative management to
avoid fracture, re-fracture, or other complications.

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Reconstruction System implants are temporary internal fixation devices. Internal fixation devices are

▪ Any retrieved devices should be treated in such a manner that reuse in another surgical procedure is not possible. As with

all orthopedic implants, the VERTEX
circumstances.

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Reconstruction System components should never be reused under any

PACKAGING

Packages for each of the components should be intact upon receipt. If a loaner or consignment system is used, all sets should
be carefully checked for completeness and all components including instruments should be carefully checked to ensure there is
no damage prior to use. Damaged packages or products should not be used, and should be returned to Medtronic.

CLEANING AND DECONTAMINATION

Unless just removed from an unopened sterile Medtronic package, all instruments and implants must be unpackaged,
disassembled (if applicable), and cleaned before sterilization, before introduction into a sterile surgical field, or if applicable,
before returning the product to Medtronic. Remove all packaging materials prior to disassembly (if applicable) and cleaning.
Cleaning instructions and associated disassembly instructions (if applicable) can be found at

Note: certain cleaning solutions such as those containing formalin, glutaraldehyde, bleach, and/or other alkaline cleaners may
damage some devices, particularly instruments (see “Medtronic Reusable Instruments” Instructions for Use – part number

0380035). Also, many instruments require disassembly before cleaning.
All products should be treated with care. Improper use or handling may lead to damage and/or possible improper functioning of

the device.

www.medtronic.com/manuals

STERILIZATION

Unless marked sterile and clearly labeled as such in an unopened sterile package provided by the company, all implants used in
surgery
should be placed in the operative field. Unless specified elsewhere, these products are recommended to be steam sterilized by
the hospital using one of the sets of process parameters in Table 1:

Table 1: Sterilization Cycle Parameters for the United States and Its Territories

METHOD CYCLE TEMPERATURE EXPOSURE TIME

Steam Gravity Displacement 250°F (121°C) 30 Minutes 30 Minutes
Steam Gravity Displacement 270°F (132°C) 15 Minutes 30 Minutes
Steam Gravity Displacement 275°F (135°C) 10 Minutes 30 Minutes
Steam Dynamic-Air-Removal 270°F (132°C) 4 Minutes 30 Minutes
Steam Dynamic-Air-Removal 275°F (135°C) 3 Minutes 16 Minutes

NOTE: Because of the many variables involved in sterilization, each medical facility should calibrate and verify the sterilization
process (e.g., temperatures, times) used for their equipment. It is the end user’s responsibility to use only sterilizers and
accessories (such as sterilization wraps, sterilization pouches, chemical indicators, biological indicators, and sterilization
cassettes) cleared by the Food and Drug Administration (FDA) for the selected sterilization cycle specifications (time and
temperature). The sterilization cycles listed in Table 2 are not considered by the FDA to be standard sterilization cycles.

*For Medical Facilities Located Outside the United States and its Territories. Some non-U.S. health care authorities
recommend sterilization according to these parameters so as to minimize the potential risk of transmission of Creutzfeldt-Jakob
disease, especially of surgical instruments that could come into contact with the central nervous system.

Table 2: Sterilization Cycle Parameters for Medical Facilities Outside the United States and Its Territories

METHOD CYCLE TEMPERATURE EXPOSURE TIME

Steam Gravity Displacement 273°F (134°C) 20 Minutes 30 Minutes
Steam Dynamic-Air-Removal 273°F (134°C) 4 Minutes 30 Minutes
Steam Dynamic-Air-Removal 273°F (134°C) 20 Minutes 30 Minutes

must be sterilized by the hospital prior to use. Remove all packaging materials prior to sterilization. Only sterile products

MINIMUM DRY TIME

MINIMUM DRY TIME

1

1

1

The minimum dry times were validated using sterilizers having vacuum drying capabilities. Drying cycles using ambient

atmospheric pressure may require longer dry times. Refer to the sterilizer manufacturer’s recommendations.

PRODUCT COMPLAINTS

Any health care professional (e.g., customer or user of this system of products) who has any complaints or who has
experienced any dissatisfaction in the product quality, identity, durability, reliability, safety, effectiveness, and/or performance,
should notify the distributor or Medtronic. Further, if any of the implanted spinal system component(s) ever “malfunctions” (i.e.,
does not meet any of its performance specifications or otherwise does not perform as intended), or is suspected of doing so, the
distributor should be notified immediately. If any Medtronic product ever malfunctions and may have caused or contributed to
the death or serious injury of a patient, the distributor should be notified immediately by telephone, fax, or written
correspondence. When filing a complaint, provide the component(s) name and number, lot number(s), your name and address,
the nature of the complaint, and notification of whether or not a written report from the distributor is requested.

MAGNETIC RESONANCE SAFETY

MR Conditional

Non-clinical testing has demonstrated that the VERTEX
performed evaluating the VERTEX

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Reconstruction System in conjunction with and without the ATLAS® Cable system. A

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Reconstruction System is MR-conditional. The non-clinical testing was

patient with this device can be safely scanned in an MR system meeting the following conditions:

▪ Static magnetic field of 1.5 Tesla or 3-Tesla.
▪ Maximum spatial gradient magnetic field of 3000 gauss/cm (30 T/m).
▪ Maximum MR system reported, whole body averaged specific absorption rate (SAR) of <2W/kg (Normal Operating Mode),

for a continuous 6 minutes of scanning per pulse sequence within a quadrature whole-body radiofrequency transmit coil.

Under the scan conditions defined above, the VERTEX
temperature rise of less than 6.8°C after 6 minutes of continuous scanning.

In non-clinical testing, the image artifact caused by the device extends 25mm from the VERTEX
imaged with a gradient echo pulse sequence in a 3.0 T MRI system.

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

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Reconstruction System is expected to produce a maximum

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Reconstruction System when

MRI Patient Counseling Information

Physicians should communicate with the patient the following information about MR with respect to the VERTEX
Reconstruction System:

▪ VERTEX

3.0 Tesla.

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Reconstruction System performance has been established for MRI systems at field strengths of 1.5 Tesla and

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▪ During an MRI, the patient may notice a warming sensation around the implant or feel a tingling sensation. If the warming or

tingling sensation is uncomfortable, the patient should communicate this to the MR technologist, the MRI should be
stopped, and the settings adjusted to reduce or eliminate the sensation. The highest temperature change observed in non­clinical testing was +6.8ºC (associated with specific conditions listed above).

▪ Additionally, the metal in the implant may cause the MRI image to be distorted in the area around the implant. The MRI can

be adjusted to minimize the image distortion.

Physicians should instruct patients to:

▪ Inform any healthcare personnel (e.g. doctor or MR technologist) that they have an implanted posterior cervical-thoracic

fusion device prior to receiving an MRI.

▪ The patient’s doctor will recommend whether or not an MRI is appropriate.

The VERTEX
environment.

If VERTEX
that this combination has not been tested in the MR environment and, therefore, higher heating and possible injury to the patient
may occur.

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Reconstruction System in conjunction with and without the ATLAS® Cable system was tested in the MR

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Reconstruction System is used in connection with any other device which is not MR Conditional, please be advised

FURTHER INFORMATION

Recommended directions for use of this system (surgical operative techniques) are available at no charge upon request. If
further information is needed or required, contact Medtronic.

©2015 Medtronic Sofamor Danek USA, Inc. All rights reserved.

AUSTRALIAN SPONSOR:

Medtronic Australasia Pty Ltd
97 Waterloo Rd
North Ryde, NSW 2113
Australia

EXPLANATION OF SYMBOLS

Authorized representative in the European Community

CAUTION: Federal law (USA) restricts these devices to
sale by or on the order of a physician.

Do not re-use

Batch code

Manufacturer

Catalogue number

Non-sterile

Medtronic Sofamor Danek USA, Inc.

1800 Pyramid Place
Memphis, TN 38132
Telephone: [phone] (USA)

901 396 3133 (Outside USA)

Fax: [phone]

Medtronic B.V.

Earl Bakkenstraat 10
6422 PJ Heerlen
The Netherlands
Tel: + 31 45 566 80 00

For US audiences only

The device complies with European Directive MDD
93/42/EEC

Sterilized using irradiation

Use-by date

MR Conditional

Consult instructions for use at this website.