Anatomic PEEK™ Cervical Fusion
M708348B066E Rev. C
System
2020-04-06
IMPORTANT INFORMATION ON THE ANATOMIC PEEK™ CERVICAL INTERBODY
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 polyetherether- ketone (PEEK) with tantalum markers and is provided sterile.
DESCRIPTION
The Anatomic PEEK™ 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. Anatomic PEEK devices must be
used with supplemental fixation.
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 Cervical Fusion System is indicated for cervical interbody fusion pro- cedures in skeletally mature patients
with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable
radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing
symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. This device is to be used in patients
who have had six weeks of non-operative treat- ment. The Anatomic PEEK device is to be used with supplemental fixation. The
Anatomic PEEK Cervical Fusion System is also required to be used 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, and is to be
implanted via an open anterior approach.
CONTRAINDICATIONS
The Anatomic PEEK™ 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 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 reprocess 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, disas- sembly, 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 Cervical Fusion System was determined to be MR Conditional based on comparison to previously
evaluated Medtronic products. A patient with this device can be safely scanned immediately after device placement under the
following conditions:
Static Magnetic Field
▪ Static magnetic field of 1.5 and 3 Tesla.
▪ Maximum spatial gradient magnetic field of 3000 - Gauss/cm or less
▪ Maximum whole body average specific absorption rate (SAR) of 2.0 W/kg or less under normal operating mode, for 15
minutes of scanning per pulse sequence.
MRI-Related Heating
In non-clinical testing, a worst case interbody device representative of the Anatomic PEEK Cervical Fusion System produced
the following temperature rises during an MRI (Magnetic Resonance Imaging) performed for 15 minutes of scanning (i.e., per
pulse sequence) in 1.5 Tesla/64 MHz MR system (Magnetom, Siemens Medical Solutions, Malvern, PA. Software Numaris/4,
Version Syngo MR 2002B DHHS Active-shielded, horizontal field scanner) and 3 Tesla/128 MHz (Excite, HDx, Software
14X.M5, General Electric Healthcare, Milwaukee, WI) MR systems:
Table 1: Temperature Rise During MRI
1.5 Tesla 3.0 Tesla
MR system reported, whole body averaged SAR 2.9 W/kg 2.9 W/kg
Calorimetry measured values, whole body averaged SAR 2.1 W/kg 2.7 W/kg
Highest temperature change 1.8˚C1.7˚C
Artifact Information
MR image quality may be compromised if the area of interest is in the same area or relatively close to the position of the
Anatomic PEEK Cervical Fusion System. Therefore, optimization of MR imaging parameters to compensate for the presence of
this device may be necessary.
MRI Patient Counseling Information
Physicians should communicate to the patient the following information about MRI with respect to the Anatomic PEEK Cervical
Fusion System:
▪ Anatomic PEEK Cervical Fusion System performance was established for MRI systems at field strengths of 1.5 and 3.0
Tesla.
▪ 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 +1.8 ºC (associated with specific conditions previously listed).
▪ 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 an implanted interbody device exists prior to receiving
an MRI.
▪ The patient’s doctor will recommend whether or not an MRI is appropriate.
If the Anatomic PEEK Cervical Fusion System is used in connection with any device which is not MR Conditional, be advised
this combination was not tested in the MR environment and, therefore, higher heating and possible injury to the patient may
occur.
Based on fatigue testing results, when using the Anatomic PEEK 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.
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™ 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 storing 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 and should personally
assemble the devices to verify all parts and 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 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
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™ 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: 800 933 2635 (USA)
901 396 3133 (Outside USA)
Fax: 901 396 0356
EXPLANATION OF SYMBOLS
CAUTION: Federal law (USA) restricts these devices to
sale by or on the order of a physician.
Consult instructions for use at this website.
Do not re-use
Batch code
Manufacturer
Catalogue number
Sterilized using irradiation
Use-by date
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