Warnings
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 vertebrae, 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, nonunion, fracture of the vertebra, neurological injury and vascular or visceral injury.
Implant Strength and Loading. The Polaris Spinal 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 because of 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 of the medical, surgical, mechanical and metallurgical aspects of the Polaris Spinal 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.
Selection of Implants. Selection of the proper size, shape and design of the implant increases the potential for success. While proper selection can help to minimize risks, the size and shape of human bones present limitations on the size and strength of implants.
Metabolic bone disease such as severe osteoporosis may adversely affect adequate fixation of the implants because of the poor quality of the bone
The surgeon must ensure that all necessary implants and instruments are on hand before surgery. They must be handled and stored carefully and protected from damage, including from corrosive environments. They should be carefully unpacked and inspected for damage before 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.
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.
The Polaris Spinal System has not been evaluated for safety and compatibility in the magnetic resonance environment and has not been tested for heating or migration in the MR environment.
The safety and effectiveness of this device has not been established for use as part of a growing rod construct. This device is intended to be used only when definitive fusion is being performed at all instrumented levels.
Please refer to the Package Insert and/or surgical technique for the proper use of these types of devices.
Precautions
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.
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.
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.
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 before complete healing.
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.
The adjustable-length rod is intended for in situ adjustment after placement of the hooks or screws during spinal fusion surgery and is intended for use as before either a single or double rod assembly. It allows for distraction at a central location once bone anchors have been secured.
The bullet end rods are intended for use with the Jackson Intrasacral Fixation Technique.
