Medtronic 5030164 Instructions for Use

Anatomic PEEK™ PTC Cervical

M708348B429E Rev. C

Fusion System

2020-10-15

IMPORTANT INFORMATION ON THE ANATOMIC PEEK™ PTC CERVICAL FUSION
SYSTEM

PURPOSE

This device is a fusion device intended for stabilization and to promote bone fusion during the normal healing process following
surgical correction of disorders of the spine. The product should be implanted only by a physician thoroughly knowledgeable in
the implant’s material and surgical aspects and instructed as to its mechanical and material applications and limitations. This
device is manufactured from medical grade polyetheretherketone (PEEK), tantalum markers, a commercially pure titanium (CP
Ti) coating, and is provided sterile.

DESCRIPTION

The Anatomic PEEK™ PTC Cervical Fusion System consists of cages of various widths and heights which can be inserted
between two cervical vertebral bodies to give support and correction during cervical interbody fusion surgeries. The hollow
geometry of the implants allows them to be packed with autogenous bone and/or allograft bone graft comprised of cancellous
and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate.

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

Medical grade tantalum, medical grade CP Ti, and medical grade PEEK may be used together. Never use titanium or titanium
alloy implants with stainless steel in the same construct.

INDICATIONS

The Anatomic PEEK™ PTC Cervical Fusion System is indicated for use in skeletally mature patients with degenerative disc
disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level or two contiguous levels. DDD is
defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The Anatomic
PEEK™ PTC Cervical Fusion System is used to facilitate intervertebral body fusion in the cervical spine and is placed via an
anterior approach from the C2-C3 disc space to the C7-T1 disc space using autogenous bone and/or allograft bone graft
comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate.
The Anatomic PEEK™ PTC Cervical Fusion System is to be used with supplemental fixation. Patients should have at least six
weeks of non-operative treatment prior to treatment with an intervertebral cage.

CONTRAINDICATIONS

The Anatomic PEEK™ PTC device is not intended for posterior surgical implantation. Contraindications include:

▪ Any medical or surgical condition which would preclude the potential benefit of spinal implant surgery such as the presence

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

▪ Any patient having inadequate tissue coverage over the operative site or where there is inadequate bone stock, bone

quality, or anatomical definition.

▪ Any patient unwilling to cooperate with postoperative instructions.
▪ Fever or leukocytosis.
▪ Infection local to the operative site and/or signs of local inflammation.
▪ Mental illness.
▪ Morbid obesity.
▪ Pregnancy.
▪ Any case not requiring fusion.
▪ Suspected or documented allergy or intolerance to the component materials.
▪ This device must not be used for pediatric cases.
▪ Patients with a known hereditary or required bone friability or calcification problem should not be considered for this type of

surgery.

▪ Prior fusion at the level to be treated.

▪ Any patient in which implant use would interfere with anatomical structures or expected physiological performance.
▪ Any case that requires the mixing of metals from two different components or systems.

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 adverse events or complications associated with spinal fusion surgery without instrumentation are possible. With
instrumentation, a listing of possible adverse events or complications includes:

▪ Bone loss or decrease in bone density possibly caused by stress shielding.
▪ Cauda equina syndrome, neuropathy, neurological deficits (transient or permanent), paraplegia, paraparesis, reflex deficits,

arachnoiditis, and/or muscle loss.

▪ Loss of spinal mobility or function.
▪ Inability to perform the activities of daily living.
▪ Change in mental status.
▪ Death.
▪ Development of respiratory problems (e.g. pulmonary embolism, atelectasis, bronchitis, pneumonia, etc.).
▪ Disassembly, bending, and/or breakage of components.
▪ Dural tears, pseudomeningocele, fistula, persistent CSF leakage, and/or meningitis.
▪ Early or late loosening of components.
▪ Implant migration.
▪ Foreign body (allergic) reaction to the implants, debris, corrosion products, including metallosis, staining, tumor formation,

and/or autoimmune disease.

▪ Fracture, microfracture, resorption, damage, penetration, and/or retropulsion of any spinal bone, of the autograft, or at the

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

▪ Ileus, gastritis, bowel obstruction or other types of gastrointestinal complications.
▪ Graft donor site complications including pain, fracture, infection, or wound healing problems.
▪ Hemorrhage, hematoma, occlusion, seroma, edema, embolism, stroke, excessive bleeding, phlebitis, damage to blood

vessels, or cardiovascular system compromise.

▪ Wound necrosis or wound dehiscence.
▪ Herniated nucleus pulposus, disc disruption, or degeneration at, above, or below the level of surgery.
▪ Infection.
▪ Loss of neurologial function, including paralysis (complete or incomplete), dysesthesia, hyperesthesia, anesthesia,

paraesthesia, appearance or radiculopathy, and/or the development or continuation of pain, numbness, neuroma, tingling
sensation, sensory loss, and/or spasms.

▪ Non-union (or pseudarthrosis), delayed union, and/or mal-union.
▪ Postoperative change in spinal curvature, loss of correction, height, and/or reduction.
▪ Scar formation possibly causing neurological compromise around nerves and/or pain.
▪ Subsidence of the device into vertebral body(ies).
▪ Tissue or nerve damage, irritation, and/or pain caused by improper positioning and placement of implants or instruments.

Note: additional surgery may be necessary to correct some of these anticipated adverse events.

WARNINGS

This system was designed for single patient use only. Do not reuse or resterilize this product. Reuse and reprocessing may
compromise the structural integrity of the device and/or create a risk of contamination of the device, which could result in patient
injury, illness, or death.

A successful result is not always achieved in every surgical case. This fact is especially true in spinal surgery where other
patient conditions may compromise the results. Use of this product in cervical interbody fusion procedures without autogenous
bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft
bone with bone marrow aspirate may 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, proper selection and placement of the
implant, and good reduction are important considerations in the success of surgery.

Patients with previous spinal surgery at the levels to be treated may have different clinical outcomes compared to those without
a previous spinal surgery.

This system should not be used in any case not described in the indications.
Further proper selection and compliance of the patient greatly affect results. Patients who smoke were 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.

PRECAUTIONS

Physician note: although the physician is the learned intermediary between the company and the patient, the important medical
information in this document should be conveyed to the patient.

Based on fatigue testing results, when using the Anatomic PEEK™ PTC Cervical Fusion System, the physician/ surgeon should
consider the levels of implantation, patient weight, patient activity level, other patient conditions, etc. which may impact the
performance of this system.

For US audiences only

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

MRI INFORMATION

The Anatomic PEEK™ PTC Cervical Fusion System has not been evaluated for safety and compatibility in the MR environment.
It has not been tested for heating, migration, or image artifact in the MR environment. The safety of Anatomic PEEK™ PTC
Cervical Fusion System in the MR environment is unknown. Scanning a patient who has this device may result in patient injury.

IMPLANT SELECTION

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

DEVICE FIXATION

Installation and positional adjustment of implants must only be done with special ancillary instruments and equipment supplied
and designated by Medtronic. In the interests of patient safety, it is therefore recommended that Medtronic implants are not
used with devices from any other source.

Never, under any circumstances, reuse an Anatomic PEEK™ PTC Cervical Fusion System device. Even when a removed
device appears undamaged, it may have small defects or internal stress patterns that may lead to early breakage.

PREOPERATIVE

▪ Only patients that meet the criteria described in the indications should be selected.
▪ Patient conditions and/or predispositions such as those addressed in the contraindications should be avoided.
▪ Care should be used when handling and storaging of the implant components. Implants should not be scratched or

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

▪ 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
surgery.

▪ The type of construct to be assembled for the case should be determined prior to surgery. An adequate inventory of implant

sizes should be available at the time of surgery including sizes larger and smaller than those expected to be used.

▪ This device is provided sterile. Additional sterile components should be available in case of an unexpected need.

INTRAOPERATIVE

▪ Instructions in any available applicable surgical technique manual should be carefully followed.
▪ At all times, extreme caution should be used around the spinal cord and nerve roots. Damage to 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.
▪ To ensure proper fusion below and around the location of the instrumentation, autogenous bone and/or allograft bone graft

comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow
aspirate must be used in all cervical interbody procedures. The graft material is to be placed in the area to be fused and the
graft material must extend from the upper vertebrae to the lower vertebrae being fused.

▪ Bone cement should not be used since this material will make removal of the components difficult or impossible. Heat

generated from the curing process may also cause neurologic damage and bone necrosis.

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, or breakage of the
device are complications which can occur as a result of excessive weight bearing or muscular activity. Risk of bending,
loosening, or breakage of a temporary internal fixation device during postoperative rehabilitation may be increased if the
patient is active,debilitated, demented, or otherwise unable to use crutches or other weight supporting devices. The patient
should be warned to avoid falls or sudden jolts in spinal position.

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

vibrations 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 or consume excess alcohol during the bone healing process.

▪ Patients should be advised of their inability to bend 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 eventual bending, loosening, or breakage of the device. It is important that
immobilization of the union is established and confirmed by roentgenographic examination. Where there is a non-union, or if
the components loosen, bend, and/or break, the device should be revised and/or removed immediately before serious injury
occurs.

▪ Retrieved devices should be treated in such a manner that reuse in another surgical procedure is not possible.

PACKAGING

Packages for components should be intact upon receipt. Once the seal on the sterile package is broken, the product should not
be re-sterilized. 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.

STERILIZATION

Anatomic PEEK™ PTC Cervical Fusion System devices are provided sterile via gamma irradiation.
Only sterile products should be placed in the operative field. Unless marked sterile and clearly labeled as such in an unopened

sterile package provided by Medtronic,implants and instruments used in surgery must be sterilized by the hospital prior to use.
Refer to the package insert of the supplemental instrumentation for sterilization information.
Sterilization instructions for instruments used with this system can be found at http://manuals.medtronic.com/. Refer to the

reprocessing instructions for general instruments– 0380035 for cleaning and sterilization instructions.

PRODUCT COMPLAINTS

To report product problems, contact Medtronic.

FURTHER INFORMATION

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

©2020 Medtronic Sofamor Danek USA, Inc. All rights reserved.

Medtronic Sofamor Danek USA, Inc.

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

901 396 3133 (Outside USA)

Fax: [phone]

EXPLANATION OF SYMBOLS

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

For US audiences only

Sterilized using irradiation

Use-by date

Consult instructions for use at this website.