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.

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.

Complications and adverse reactions have been reported with the use of similar spinal instrumentation systems. These adverse effects, including the possibility of death, should be discussed with the patient prior to surgery.

• Non-union, delayed union
• Bending or fracture of implant. Fraying, kinking, loosening, bending or breaking of any or all implant components.
• Loosening of or migration of the implant
• Metal sensitivity or allergic reaction to a foreign body
• Infection
• Decrease in bone density due to stress shielding
• Pain, discomfort, or abnormal sensations due to the presence of the device
• Loss of the natural curvature of the spine
• Modification of the spinal geometric corrections of the vertebral and/or intervertebral height and/or of the reduction in spinal deformities
• Vascular and/or nerve damage due to surgical trauma
  or presence of the device.
• Neurological difficulties including bowel and/or bladder dysfunction, impotence, retrograde ejaculation and paraesthesia.
• Bursitis
• Dural leak
• Paralysis
• Death
• Erosion of blood vessels due to the proximity of the device,
  leading to hemorrhage and/or death
• Additional surgery may be required to correct any of these potential adverse effects
  • Additional Potential Adverse Effects for Pediatric Patients:
  • Inability to use pedicle screw fixation due to anatomic limitations (pedicle dimensions, distorted anatomy)
  • Pedicle screw malpositioning, with or without neurological or vascular injury
  • Proximal or distal junctional kyphosis
  • Pancreatitis

Other adverse events related to pedicle screw fixation, such as screw or rod bending, breakage, or loosening,
may also occur in pediatric patients and pediatric patients may be at increased risk for device-related injury because of their smaller stature.