Cypher™ MIS Screw System

DESCRIPTION

The Cypher™ MIS Screw System is a non-cervical spinal fixation device. The system includes screws, various types and sizes of rods, and set screws. Various instruments are also available for use by the surgeon to facilitate implantation of the device.

INDICATIONS

The Cypher MIS Screw System is a non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion as a pedicle screw fixation system or sacral/iliac screw fixation system for use with autograft and/or allograft. The Cypher Instruments are intended to be used with the Cypher/Polaris™ 5.5 implants. Cannulated screws and percutaneous rods may be used with the Cypher instruments to provide the surgeon with a percutaneous approach for posterior spinal surgery for the following conditions: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformity or curvature (i.e., scoliosis, kyphosis, Scheuermann’s disease, and/or lordosis), tumor, stenosis, pseudoarthrosis, and failed previous fusion.

The Cypher MIS Screw System may be used with the instruments in the AccuVision® Minimally Invasive Spinal Exposure System to provide the surgeon with a minimally invasive approach for posterior spinal surgery.

CONTRAINDICATIONS

1. Spinal infection
2. Morbid obesity
3. A patient who in the surgeon’s opinion is not psychosocially, mentally or physically able to fully comply with the post-operative treatment regime (e.g., mental illness, alcoholism or drug abuse.)
4. Pregnancy
5. Metal sensitivity/foreign body sensitivity
6. Patients with inadequate tissue coverage over the operative site
7. Open wounds local to the operative area

WARNINGS

1.  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 neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown. Potential risks identified with the use of this device, which may require additional surgery, include device component fracture, loss of fixation, non-union, fracture of the vertebra, neurological injury, and vascular or visceral injury.
2. Implant Strength and Loading. The Cypher MIS Screw System is intended to assist healing and is not intended to replace normal bony structures. Loads produced by weight bearing and activity levels will dictate the longevity of the implant. These devices are not designed to withstand the unsupported stress of full weight bearing or load bearing, and cannot withstand activity levels and/or loads equal to those placed on normal healthy bone. If healing is delayed or does not occur, the implant could eventually break due to metal fatigue.
   
   Therefore, it is important that immobilization of the operative site be maintained until firm bony union (confirmed by clinical and radiographic examination) is established. The surgeon must be thoroughly knowledgeable in the medical, surgical, mechanical and metallurgical aspects of the Cypher MIS Screw System. Postoperative care is extremely important. The patient should be warned that noncompliance with postoperative instructions could lead to breakage of the implant and/or possible migration requiring revision surgery to remove the implant.
3. Selection of Implants. Selection of the proper size, shape and design of the implant increases the potential for success. While proper selection can help minimize risks, the size and shape of human bones present limitations on the size and strength of implants.
4. Metabolic bone disease such as severe osteoporosis may adversely affect adequate fixation of the implants due to the poor quality of the bone.
5. The surgeon must ensure that all necessary implants and instruments are on hand prior to surgery. They must be handled and stored carefully, protected from damage, including from corrosive environments. They should be carefully unpacked and inspected for damage prior to use. All nonsterile components and instruments must be cleaned and sterilized before use.
   
   Zimmer Biomet Spine implants should not be used with implants or instruments from another manufacturer for reasons of metallurgy, mechanics and design.
6. Corrosion. Contact of dissimilar metals accelerates the corrosion process, which could increase the possibility of fatigue fracture of the implants. Therefore, only use like or compatible metals for implants that are in contact with each other. Never use stainless steel and titanium implant components in the same construct. Cobalt Chrome Alloy rods should not be used with Stainless Steel Components. Cobalt Chrome Alloy rods are to be used ONLY with titanium implant components in the same construct.
7. The Cypher MIS Screw System has not been evaluated for safety and compatibility in the MR environment and has not been tested for heating or migration in the MR environment.
8. The safety and effectiveness of this device has not been established for use as part of a growing rod construct. This device is only intended to be used when definitive fusion is being performed at all instrumented levels.
9. Direct current stimulation has proven detrimental to the structural integrity of the Cypher MIS Cannulated Translation Screw. As such, a construct that includes the Cypher MIS Cannulated Translation Screw should not come in contact with direct current stimulation devices. Please refer to the Package Insert and/or surgical technique for the proper use of these types of devices.

PRECAUTIONS

1. Do not reuse implants/devices. While an implant/device may appear undamaged, previous stress may have created imperfections that would reduce the service life of the implant/ device. Do not treat patients with implants/devices that have been even momentarily placed in or used on a different patient.
2. Handling of Implants. If contouring of the rod is required, avoid sharp bends and reverse bends. Avoid notching or scratching of the device, which could increase internal stresses and lead to early breakage.
3. Implant Removal After Healing. After healing is complete, the implant is intended to be removed since it is no longer necessary. Implants that are not removed may result in complications such as implant loosening, fracture, corrosion, migration, pain or stress shielding of bone, particularly in young, active patients. Implant removal should be followed by adequate postoperative management.
4. Adequate Patient Instructions. A patient must be instructed on the limitations of the metallic implant, and should be cautioned regarding physical activity and weight bearing or load bearing prior to complete healing.
5. Surgical Techniques. The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of pedicle screw spinal systems because this is a technically demanding procedure presenting a risk of serious injury to the patient. Please refer to the specific surgical technique for this device for more information. For a copy of the surgical technique, please contact your sales representative, or customer service at the address provided on the cover.

POSSIBLE ADVERSE EFFECTS

1. Nonunion (pseudarthrosis) fibrous union (pseudoarthrosis), delayed union or mal-union
2. Loss of fixation malfunction, disassembly, pull-out, or bending, fracture, loosening or migration of the implant or instruments
3. Metal sensitivity or foreign body reaction to implant materials including corrosion by-products due to use of dissimilar implant materials, possible tumor formation, skin or muscle sensitivity in patients with inadequate tissue coverage over the operative site, which may result in skin breakdown and/or wound complications
4. Decrease in bone density due to stress shielding
5. Pain, discomfort, or abnormal sensations including back/leg pain due to presence of the implant or surgical procedure
6. Nerve, soft tissue, or blood vessel damage due to surgical trauma including loss of neurological function, dural tears, radiculopathy, paralysis and cerebral spinal fluid leakage
7. Gastrointestinal, urological and/or reproductive system compromise, including sterility, impotency and/or loss of consortium
8. Fracture of bony structures at, above or below the level of surgery (fracture of the vertebra)
9. Nerve root or spinal cord impingement
10. Bursitis
11. Necrosis of bone
12. Hemorrhage of blood vessels, blood clots, and/or hematomas
13. Malalignment of anatomical structures, including loss of proper spinal curvature, correction, reduction and/or height
14. Bone graft donor site pain
15. Inability to resume activities of normal daily living
16. Neurological, vascular or visceral injury
17. Reoperation
18. Infection/sepsis
19. General surgical complications including cardiac or respiratory issues, exposure to radiation, thrombosis, skin irritation, wound problems, issues related to anesthesia and/or allergic reaction to grafting material
20. Implant malposition
21. Graft settling/displacement
22. Death