Indications, Safety, and Warnings

Purpose

The purpose of the Medtronic Centerpiece™ Plate Fixation System is to provide a means to prevent expulsion of graft material after a laminoplasty has been performed.

Description

The Centerpiece Plate Fixation System consists of a variety of sizes of plates and screws. The Centerpiece Plate Fixation System components are made of medical grade titanium or titanium alloy. No warranties, express or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded. See the Medtronic Sofamor Danek catalog and/or pricelist for further information about warranties and limitations of liability.

Indications

The Medtronic Centerpiece Plate Fixation System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The Centerpiece Plate Fixation System is used to hold the graft material in place in order to prevent the graft material from expulsion, or impinging on the spinal cord.

Contraindications

Contraindications include, but are not limited to:

1. Infection, local to the operative site.
2. Fever or leukocytosis.
3. Morbid obesity.
4. Pregnancy.
5. Mental illness.
6. Any medical or surgical condition which would preclude potential benefit of spinal implant surgery, such as the presence of tumors or congenital abnormalities, elevation of sedimentation rate unexplained by other diseases, elevated white blood count (WBC), or a marked left shift in the WBC differential count.
7. 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.
8. Suspected or documented metal allergy or intolerance.
9. Any case needing to mix metals from different components.
10. Any case not needing a laminoplasty procedure.
11. Any patient having inadequate tissue coverage over the operative site, or inadequate bone stock or bone quality.
12. Any time implant utilization would interfere with anatomical structures or expected physiological performance.
13. Any patient who will not follow postoperative instructions, such as drug/alcohol abuse patients, and are unwilling to restrict postoperative activities.
14. Any case not described in the Indications.
15. Any patient unwilling to follow the postoperative instructions.

Contraindications of this device are consistent with those of other anterior spinal instrumentation systems. This spinal implant system is not designed, intended, or sold for uses other than those indicated.

Possible Adverse Effects

1. Early or late loosening of the components.
2. Implant migration.
3. Disassembly, bending, loosening, slippage, and/or breakage of any or all of the components or instruments.
4. Foreign body reaction to the implants including possible tumor formation, autoimmune disease, metallosis, and/or scarring.
5. Pressure on the skin possibly resulting in skin breakdown from component parts where there is inadequate tissue coverage over the implant. Implant or graft extrusion through the skin. Wound complications.
6. Loss of proper spinal curvature, correction, height, and/or reduction.
7. Infection.
8. Bone fracture or stress shielding at, above, or below the level of surgery.
9. Loss of neurological function, appearance of radiculopathy, dural tears, and/or development of pain. Neurovascular compromise including paralysis or other types of serious injury. Cerebral spine fluid leakage.
10. Gastrointestinal, urological, and/or reproductive system compromise, including sterility, impotency, and/or loss of consortium.
11. Hemorrhage of blood vessels and/or hematomas.
12. Discitis, arachnoiditis, and/or other types of inflammation.
13. Deep venous thrombosis, thrombophlebitis, and/or pulmonary embolus.
14. Inability to resume activities of normal daily living.
15. Death.

Note: Additional surgery may be necessary to correct some of these anticipated adverse reactions.

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 system is intended to be used to provide protection of the spinal canal. The safety and effectiveness of the device when implanted in the anterior spine have not been established. Preoperative and operating procedures, including knowledge of surgical techniques, proper reduction, and proper selection and placement of the implant are important considerations in the successful utilization of the Centerpiece Plate Fixation System by the surgeon. Further, the proper selection and compliance of the patient will greatly affect the results.

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 U.S. Audiences Only

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

Other preoperative, intraoperative, and postoperative warnings are as follows:

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, loosening, or migration of the device, which may result in further injury or the need to remove the device prematurely.

Preoperative

1. Only patients that meet the criteria described in the indications should be selected.
2. Patient conditions and/or predispositions such as those addressed in the aforementioned contraindications should be avoided.
3. Use care in the handling and storage of implant components. Implants should not be scratched or damaged. Implants and instruments should be protected during storage especially from corrosive environments.
4. The type of construct to be assembled for the case should be determined prior to beginning the surgery.
5. 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 Centerpiece Plate Fixation System components are not to be combined with the components from another manufacturer. Different metal types should not be used together.
6. Unless sterile packaged, all parts should be cleaned and sterilized before use. Additional sterile components should be available in case of an unexpected need.

Intraoperative

1. Any instruction manuals, if available, should be carefully followed.
2. 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.
3. Implant surfaces should not be scratched or notched, since such actions may reduce the functional strength of the construct.
4. Never over-tighten screws so as to prevent stripping of the threads. Recheck the tightness of all screws after finishing to ensure that none have loosened during the tightening of the other screws. Failure to do so may cause loosening.

Postoperative

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

1. Detailed instructions on the use and limitations of the device should be given to the patient. The risk of bending, loosening, or breakage of an 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, sudden jolts, or sudden blows to the spine.
2. 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 that may cause sharp forces to the posterior cervical spine.

Packaging

Packages for each of the components should be intact upon receipt. If a loaner, earn-out or consignment system is used, all sets should be carefully checked for completeness and all components should be carefully checked for lack of damage prior to use. Damaged packages or products should not be used, and should be returned to Medtronic Sofamor Danek.

Cleaning and Decontamination

Unless just removed from an unopened Medtronic Sofamor Danek 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 Sofamor Danek. Cleaning and disinfecting of instruments can be performed with aldehyde-free 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.

Sterilization

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.

These products are recommended to be steam sterilized by the hospital using one of the three sets of process parameters below:

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.

*Outside the United States, some non-U.S. health care authorities recommend sterilization according to these parameters 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.

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 Centerpiece^™ Plate Fixation 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.

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, please contact Medtronic at (800) 876-3133