Vital™ Spinal Fixation System

Vital

The Vital Spinal Fixation System is a subsystem of the Vitality Spinal Fixation System

Important Information for the Vitality Spinal Fixation System

Before using a product placed on the market by Zimmer Biomet, the operating surgeon should study carefully the following recommendations, warnings and instructions, as well as the available product-specific information (e.g., product literature, written surgical technique). Zimmer Biomet is not liable for complications that may arise from the use of the device in circumstances outside of Zimmer Biomet’s control including, but not limited to, product selection and deviations from the device’s intended uses or surgical technique.

Compatibility between all Zimmer Biomet Spine product lines, including acquisitions of pre-existing product lines, has not been established. Only authorized combinations of products should be used. Only use as indicated in the Instructions for Use (Package Insert) and/or the Surgical Technique.

Product 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.

Refer to the Vitality Spinal Fixation System Surgical Technique Guide for additional information on how to use this device. Contact your Zimmer Biomet Spine Sales Representative or Zimmer Biomet Customer Service for a copy of the current Surgical Technique.

Indications

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 Zimmer Biomet Spine, using rod connectors.

* These optional components are not approved in all regions.

Contraindications

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.
  
  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.

Additional preoperative, intraoperative, and postoperative warnings and precautions:

PREOPERATIVE

• Usage of automated cleaning processes without supplemental manual cleaning may not result in adequate cleaning of instruments.
• Proper handling, decontamination (including pre-rinsing, washing, rinsing and sterilization), storage and utilization are important for the long and useful life of all surgical instruments. Even with correct use, care and maintenance, they should not be expected to last indefinitely. This is especially true for cutting instruments (e.g., bone awls/drills) and driving instruments (e.g., drivers). These items are often subjected to high loads and/or impact forces. Under such conditions, breakage can occur, particularly when the item is corroded, damaged, nicked or scratched.
• Never use titanium, titanium alloy, and/or cobalt chromium with stainless steel in the same implant construct; otherwise, galvanic corrosion may occur.
• Zimmer Biomet does not specify the maximum number of times a re-usable instrument may be re-used. The useful life of these instruments is highly dependent on a number of factors including the frequency and manner in which they are used and the handling they experience in between uses. Inspection and, where appropriate, functional testing prior to using, is the best way to determine whether or not an individual device should be used.

INTRAOPERATIVE

• If contouring of the implant is necessary for optimal fit, the contouring should be gradual and avoid any notching or scratching of the implant surface. Do not repeatedly or excessively bend the implant. Do not reverse bend the rods.
• Pedicle bone integrity should be verified.
• Care should be taken during pedicle preparation to avoid penetrating too deep.
• Care should be taken during bone preparation to avoid damage to the pedicle and to the surgical instruments.
• Care should be taken to minimize soft tissue damage during surgery.
• Care should be taken to avoid removing excess material from the lamina.
• Care should be taken to avoid cross-threading screws and closure tops.
• If any implant or instrument comes in contact with a non-sterile surface it should not be used.

POSTOPERATIVE

• Adequately instruct the patient. Postoperative care and the patient’s ability and willingness to follow instructions are one of the most important aspects of successful bone healing. The patient must be made aware of the limitations of the implant and that physical activity and full weight bearing have been implicated in fracture. The patient should understand that an implant is not as strong as normal, healthy bone and will fracture if excessive demands are placed on it in the absence of complete bone healing. An active, debilitated, or demented patient who cannot properly use weight-supporting devices may be particularly at risk during postoperative rehabilitation.
• The Vitality System is a temporary internal fixation device. Internal fixation devices are designed to stabilize the operative site during the normal healing process. After healing occurs, these devices serve no functional purpose and should be removed. Implant removal should be followed by adequate postoperative management to avoid fracture or refracture.

ADVERSE EFFECTS

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.