Vital™ Power Instrument Kit

Device Description
The Vitality Spinal Fixation System is a thoracolumbar and sacroiliac fixation system designed to aid in the surgical correction of several types of spinal conditions. The system consists of a variety of spinal rods, pedicle screws, hooks and connectors intended only to provide temporary stabilization during the development of a solid fusion of the spine with bone graft. The system can be rigidly locked into a variety of configurations, with each construct being customized to the patient’s anatomy. All implants are single use only and should not be reused under any circumstances. The implant system is intended to be removed after solid fusion has occurred. The system also includes instrumentation for insertion, securing and removal of the implants. All implants are made from medical grade titanium alloy; select rods are also available in medical grade cobalt chromium alloy. Implants made from medical grade titanium, medical grade titanium alloy, and medical grade cobalt chromium may be used together. Never use titanium, titanium alloy, and/or cobalt chromium with stainless steel in the same implant construct. The Vitality Spinal Fixation System is compatible with components from other cleared spinal fixation systems. See Indications below.

Intended Use
Vital Power instruments and adapters are intended for use with the ZimVie Universal Power System to facilitate the preparation of the pedicle and ilium and insertion of Vitality Spinal Fixation System screws using a power surgical technique. Pedicle and iliac screws from the Vitality Spinal Fixation System may be implanted in the non-cervical spine using powered instrumentation during spinal surgery, including open and minimally invasive procedures.

Indications for Use
The Vitality Spinal Fixation System implants are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients. These devices are indicated as an adjunct to fusion for all of the following indications: 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), deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis, Scheuermann’s Disease), tumor, stenosis, pseudoarthrosis and/or failed previous fusion. When used as an adjunct to fusion, the Vitality Spinal Fixation System is intended to be used with autograft and/or allograft.

In addition the Vitality Spinal Fixation System is intended for treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and or ilium with removal of the implant after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Vitality System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Vitality System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The use of the Vitality Spinal Fixation System in skeletally mature patients may include the fixation of the Instinct® Java™ Spinal Fixation System* hooks, APEX Spinal System™* hooks, or fixation of the Universal Clamp® Spinal Fixation System* to the rods of the Vitality Spinal Fixation System. The Vitality Spinal Fixation System may also be used in skeletally immature patients when connected with the Universal Clamp Spinal Fixation System. In order to achieve additional levels of fixation in skeletally mature patients, the Vitality Spinal Fixation System* may be connected to the Virage® OCT Spinal Fixation System and the Instinct Java Spinal Fixation System offered by ZimVie Spine, using rod connectors.

Contradictions
The Vitality System is not designed or sold for any use except as indicated. Do not use the vitality system implants in the presence of any contraindication.

• Insufficient bone quantity, severe osteoporosis, or other condition that might compromise rigid fixation of the device.
• A history of infection, active systemic infection or infection localized to the site of the proposed implantation.
• Suspected or documented metal allergy or intolerance.
• A disorder affecting the normal process of bone remodelling, including but not limited to severe osteoporosis involving the spine, excessive bone reabsorption, osteopenia, a primary or metastatic tumor involving the spine, or certain metabolic disorders of osteogenesis.
• Iliac screws and offset connectors should not be used in cases of tumor or trauma of the sacrum, when additional screw fixation in S1 is not possible.

Other relative contraindications include obesity, pregnancy, certain degenerative diseases, and foreign body sensitivity. In addition, the patient’s occupation or activity level or mental capacity may be relative contraindications to this surgery. Specifically, some patients may, because of their occupation or lifestyle, or because of conditions such as mental illness, alcoholism or drug abuse, place undue stresses on the implant.

Warnings and Precautions

Following are specific warnings, precautions, and adverse effects associated with use of the Vitality System that should be understood by the surgeon and explained to the patients. General surgical risk should be explained to the patients prior to surgery.

• Implantation of the Vitality System should be performed only by experienced spinal surgeons.
• All implants are intended for single use only. Single use devices should not be re-used. Possible risks associated with re-use of single-use devices include:
  • Mechanical malfunction
  • Transmission of infectious agents
• Metal sensitivity has been reported following exposure to orthopedic implants. The most common metallic sensitivities (nickel, cobalt, and chromium) are present in medical grade stainless steel and cobalt-chrome alloys.
• Universal precautions should be observed by all end users that work with contaminated or potentially contaminated medical devices. Caution should be exercised when handling devices with sharp points or cutting edges to prevent injuries during and after surgical procedures and reprocessing.
• Warning: 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 neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.
• Warning: The safety and effectiveness of this device has not been established for use as part of a growing rod construct. The device is only intended to be used when definitive fusion is being performed at all instrumented levels.
• Additional Warnings for Pediatric Patients: The use of pedicle screw fixation in the pediatric population may present additional risks when patients are of smaller stature and skeletally immature. Pediatric patients may have smaller spinal structures (pedicle diameter or length) that may preclude the use of pedicle screws or increase the risk of pedicle screw malpositioning and neurological or vascular injury. Patients who are not skeletally mature undergoing spinal fusion procedures may have reduced longitudinal spinal growth, or may be at risk for rotational spinal deformities (the “crankshaft phenomenon”) due to continued differential growth of the anterior spine.
• Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.
• Additional Precautions for Pediatric Patients: The implantation of pedicle screw spinal systems in pediatric patients should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system in pediatric patients because this is a technically demanding procedure presenting a risk of serious injury to the patient.

Pre-operative

• Patient selection is extremely important. In selecting patients for total disc replacement, the following factors can be of importance to the success of the procedure: the patient’s occupation or activity level, prior injury or other ongoing illness, alcoholism, or drug abuse; and certain degenerative diseases (e.g., degenerative scoliosis or ankylosing spondylitis) that may be so advanced at the time of implantation that the expected useful life of the device is substantially decreased.
• In order to minimize the risk of periprosthetic vertebral fractures, surgeons must consider all co-morbidities, past and present medications, previous treatments, etc. A screening questionnaire for osteopenia or osteoporosis, SCORE (Simple Calculated Osteoporosis Risk Estimation), may be used to screen patients to determine if a DEXA bone mineral density measurement is necessary. If DEXA is performed, the patient should be excluded from receiving the device if the DEXA bone density measured T score is < -1.5, as the patient may be osteoporotic or osteopenic.
• The patient should be informed of the potential adverse effects (risks/complications) contained in the insert (see ADVERSE EVENTS).
• Preoperative planning may be used to estimate the required implant size and to assure that the appropriate range of sizes is available for surgery. The procedure should not take place if the appropriate range of sizes will not be available.
• Examine all instruments prior to surgery for wear or damage. Instruments which have been used excessively may be more likely to break. Replace any worn or damaged instruments.

 

Intra-operative

• Use aseptic technique when removing the Mobi-C® from the innermost packaging. Carefully inspect each component and its packaging for any signs of damage, including damage to the sterile barrier. Do not use Mobi-C® implants if the packaging is damaged or the implant shows signs of damage.
• Use care when handling the Mobi-C® to ensure that it does not come in contact with objects that could damage the implant. Damaged implants are no longer functionally reliable. Visual inspection of the prosthesis assembly is recommended prior to implanting the device. If any part of the assembly appears damaged or not fully assembled, do not use.
• To prevent unnecessary damage to the bearing surfaces, ensure that tissue or other debris is not trapped within the device.
• The Mobi-C® should not be used with components or instruments of spinal systems from other manufacturers. See the surgical technique for step by step instructions.
• Surgical implants must never be re-used or reimplanted. Even though the device appears undamaged, it may have small defects and internal stress patterns that may lead to early breakage.
• Perform a complete discectomy of the disc space between the unci and up to the posterior ligament. Take care to release the foramen bilaterally. It is important to remove all anterior and posterior osteophytes on the superior and inferior vertebral endplates. Liberally cover bleeding with bone wax. To prevent weakening of the endplates, use of a burr is discouraged during endplate preparation. Use the Caspar Retractor as needed to maintain or modify distraction. Ensure proper alignment and placement of device components as misalignment may cause excessive wear and/or early failure of the device.

 

Post-operative

• Patients should be instructed in postoperative care procedures and should be advised of the importance of adhering to these procedures for successful treatment with the device including the avoidance of heavy lifting, repetitive bending, and prolonged or strenuous activity initially and for a period of weeks to months depending on the individual patient’s progress and the stability and functioning of the implant.
• Note to Physician: 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.