Navigation Array Kit for Brainlab®

INDICATIONS FOR USE

The Vital Navigation System instruments are used during the preparation and placement of the Vital  and Vitality System screws during spinal surgery to precisely locate anatomical structures in either open or minimally invasive procedures. The Vital Navigation System instruments are designed for use with either the Medtronic StealthStation S7 or the Brainlab Spine & Trauma Navigation software. The ZimVie reference arrays can only be used with the Brainlab Spine & Trauma Navigation System. 

CONTRAINDICATIONS

The Vital Navigation System is not designed or sold for any use except as indicated. DO NOT USE THE VITAL NAVIGATION SYSTEM INSTRUMENTS 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 remodeling, 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.
• The Vital Navigation System is contraindicated for any conditions listed for the Medtronic Navigation System and the compatible Vital and Vitality implant systems.
• The Vital Navigation system reference arrays are contraindicated for use  with any instrumentation other than the Vital Navigation System instruments, and any navigation system other than the Brainlab Spinal Navigation System

WARNINGS AND PRECAUTIONS

Following are specific warnings, precautions, and adverse effects associated with use of the Vital Navigation System that should be understood by the surgeon and explained to the patients. Surgeons should be thoroughly familiar with these instructions, in addition to all other product labeling. 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.
• ZimVie does not warrant Medtronic or Brainlab Navigation Software. It is the sole responsibility of the user to ensure instrument calibration and/or registration.
• The Use of the Vital Navigation System should only be used with the indicated Vital and Vitality screw systems.
• Users must complete verification steps as required per the Medtronic or Brainlab Navigation Technique.
• Users must ensure that surgical accuracy be assessed before the procedure and repeatedly throughout the procedure by positioning the tip of each navigated instrument on an identifiable anatomical landmark and comparing the actual tip location to that displayed by the system. When verifying the accuracy of the Navigated Drivers, the accuracy test must include the screw (of which diameter and length are selected/entered into the software) assembled securely onto the driver.  The screw tip will be placed on an identifiable anatomical landmark and compared to the tip location as displayed on the screen.
• In the event of a registration failure or suspected inaccuracy, the Navigated Instruments should not be used with the Navigation System and the instruments should be inspected for damage before continuing with the traditional, non-navigated procedure.
• The Vital Navigation System instruments should not be bent or altered in any way as this could lead to a reduction in system accuracy.
• 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.

• 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.
• 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.
• Preoperative and operating procedures, including knowledge of surgical techniques, good reduction, and proper selection and placement of the implants are important considerations in the successful utilization of the system in pediatric patients.
• The selection of the proper size, shape and design of the implant for each patient is crucial to the safe use of this device in pediatric patients.