Indications, Safety, and Warnings
The PEEK Prevail Cervical Interbody Device is indicated for anterior cervical interbody fusion procedures 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. The PEEK Prevail Cervical Interbody Device must be used with internal screw fixation provided by Zephir Anterior Cervical Screws. The PEEK Prevail Cervical Interbody Device implants are to be used with autograft and implanted via an open, anterior approach. This cervical device is to be used in patients who have had six weeks of non-operative treatment.
The PEEK Prevail Cervical Interbody device is not intended for posterior surgical implantation. Contraindications include, but are not limited to:
- Any case needing to mix metals from different components.
- Any case not described in the indications.
- 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 the WBC 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 co-operate with postoperative instructions.
- Fever or leukocytosis.
- Infection, local to the operative site.
- Mental illness.
- Morbid obesity.
- Rapid joint disease, bone absorption, osteopenia, and/or osteoporosis. Osteoporosis is a relative contraindication since this condition may limit the degree of obtainable correction and/or the amount of mechanical fixation.
- Signs of local inflammation.
- Suspected or documented metal allergy or intolerance. These devices must not be used for pediatric cases, nor where the patient still has general skeletal growth. Contraindications of this device are consistent with those of other spinal systems.
Potential Adverse Events
All of the possible adverse events or complications associated with spinal fusion surgery without instrumentation are possible. With instrumentation, a listing of possible adverse events or complications includes, but is not limited to:
- 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.
- Cessation of any potential growth of the operated portion of the spine. Loss of spinal mobility or function. Inability to perform the activities of daily living.
- Change in mental status.
- Development of respiratory problems, e.g., pulmonary embolism, atelectasis, bronchitis, pneumonia, etc.
- Disassembly, bending, and/or breakage of any or all of the components.
- Dural tears, pseudomeningocele, fistula, persistent CSF leakage, meningitis.
- Early or late loosening of the 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.
- 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.
- 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. 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, irrigation, 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.
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. The PEEK Prevail Cervical Interbody Device must be used with the Zephir Anterior Cervical Screws to augment stability. Use of this product without autograft 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. Never reuse an internal fixation device under any circumstances. Even when a removed device appears undamaged, it may have small defects or internal stress patterns that may lead to early breakage. Damage of the thread will reduce the stability of the instrumentation. 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.
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 patients.
FOR US AUDIENCES ONLY
Caution: Federal Law (USA) restricts these devices to sale by or on the order of a physician.
The selection of the proper size, shape and design of the implant for each patient is crucial to the success of the procedure. Plastic polymer 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 material 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.
- Only patients that meet the criteria described in the indications should be selected.
- Patient conditions and/or predispositions 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 damaged. Implants and instruments should be protected during storage especially from corrosive environments.
- Further information on the use of this system will be made available on request.
- 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 that all parts and necessary instruments are present before the surgery begins.
- The type of construct to be assembled for the case should be determined prior to beginning the 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.
- Unless sterile packaged, all parts should be cleaned and sterilized before use. Additional sterile components should be available in case of an unexpected need.
- The 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 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.
- To assure proper fusion below and around the location of the instrumentation, autograft should be used. Autograft must be placed in the area to be fused and graft material must extend from the upper to the lower vertebrae being fused. When using the Peek Prevail Cervical Interbody device, autograft should be used.
- Bone cement should not be used since this material will make removal of the components difficult or impossible. The heat generated from the curing process may also cause neurologic damage and bone necrosis.
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. 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, 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 the 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.
- The 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.
- Any retrieved devices should be treated in such a manner that reuse in another surgical procedure is not possible.
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 that 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 Medtronic package, all instruments and implants must be disassembled (if applicable) and cleaned using neutral cleaners before sterilization and introduction into a sterile surgical field or (if applicable) return of the product to Medtronic. Cleaning and disinfecting of instruments can be performed with aldehydefree solvents at higher temperatures. Cleaning and decontamination must include the use of neutral cleaners followed by a deionized water rinse.
NOTE: Certain cleaning solutions such as those containing formalin, glutaraldehyde, bleach and/or other alkaline cleaners may damage some devices, particularly instruments; these solutions should not be used. 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.
The contents of the implant package for the Peek Prevail Cervical Interbody Device are provided sterile via gamma irradiation. The Zephir® Anterior Cervical Screws and general instruments used with the Peek Prevail Cervical Interbody Device are provided non-sterile.
Unless marked sterile and clearly labeled as such in an unopened sterile package provided by the company, all implants and instruments used in surgery must be sterilized by the hospital prior to use. Remove all packaging materials prior to sterilization. Only sterile products 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 below:
|Steam||Pre-Vacuum||270°F (132°C)||4 Minutes|
|Steam||Gravity||250°F (121°C)||60 Minutes|
|Steam*||Pre-Vacuum*||273°F (134°C)*||20 Minutes*|
|Steam*||Gravity*||273°F (134°C)*||20 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.
*For outside the United States, 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.
Remove all packaging material prior to sterilization. Only sterile implants and instruments should be used in surgery. No implant should be re-used once it comes into contact with human tissue or body fluid. Always immediately clean and re-sterilize instruments that have been used in surgery. This process must be performed before handling or (if applicable) returning to Medtronic.
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, please provide the component(s) name and number, lot number(s), your name and address, the nature of the complaint and notification of whether a written report from the distributor is requested.
Recommended directions for use of this system (surgical operative techniques) are available at no charge upon request. If further information is needed or required, please contact Medtronic.
1800 Pyramid Place
Memphis, TN 38132
Telephone 800 933 2635 (In U.S.A.)
901 396 3133 (Outside of U.S.A.)
Fax 901 396 0356
Please contact Customer Service or your Sales Representative for the most up-to-date package insert.