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Zimmer, Inc.

Virage® OCT Spinal Fixation System

Product Description

The Virage System is an Occipital-Cervico-Thoracic (OCT) fusion system that will change your perspective on posterior fixation.  Virage, meaning a “change in perspective,” or “a movement in a new direction,” reflects how Zimmer’s 360° Omnidirectional Extreme-Angle Screw brings a new experience to posterior fixation surgery.

Features

  • The 360° Omnidirectional Extreme-Angle Screw:  All Virage System polyaxial dual-lead screws incorporate 360° Omnidirectional Extreme-Angle Screw technology, allowing for 112° of conical range of motion, simplifying rod alignment. The proprietary friction-fit screw head holds the desired rod position, facilitating rod placement.  Screws have dual-lead screw threads, requiring fewer revolutions, and are available in ø3.5mm, ø4.0mm, ø4.5mm and ø5.0mm (smooth shank options available in ø3.5mm and ø4.0mm) in multiple lengths.

  • Head-to-Head Transverse Connectors (HHTC) provide multi-planar motion, allowing for off-axis screw head positioning, 20° of polyaxial motion to eliminate cross-connector bending, unlimited rotation in the sagittal plane for preferred placement, are designed to minimize profile, and are available in five sizes in 27-53 mm lengths (note: there is a 1mm overlap between sizes)

  • Rod-to-Rod Transverse Connectors have a snap on-design for easier implantation and a locking system positioned lateral to the spinal cord

  • Multiple Rod Options available in cobalt chrome and titanium, with pre-bent ø3.5mm/5.5mm transition rods

  • Occipital Rods with 64° to 180° range of motion eliminate bending, have 3.5mm to 3.8mm transition at hinge to increase rod strength at the occipital level, with pre-bent occipital rods at 100° and 130°

  • Low-Profile Occipital Plates are available in three sizes to accommodate patient anatomy, include a strap option for additional fixation, have lower rod connection to minimize soft tissue irritation, and have rotational and translational adjustability

  • Occipital Screws are available in ø4.5mm and ø5.25mm with 6-16mm lengths

  • Instruments Engineered for Performance: the sleek design delivers efficient results in the operating room to overcome challenging patient anatomies during OCT fusion procedures

ZS-SA0700-42_A


Device Description

The Zimmer Spine Virage OCT Spinal Fixation System is a posterior system intended for the Occipital-Cervical-Thoracic spine (Occiput-T3). The system consists of a variety of rods, anchors, transverse connectors, screws, and polyaxial screws to achieve an implant construct as necessary for the individual case. The system also includes the instruments necessary for inserting and securing the implants. The implant system is intended to be removed after solid fusion has occurred. The Virage System implants are fabricated from medical grade titanium alloy and 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 construct. All implants are single use only and should not be reused under any circumstances.

Indications

When intended to promote fusion of the occipitocervical spine, cervical spine and the thoracic spine, (Occiput -T3), the Virage OCT Spinal Fixation System is indicated for the following: Degenerative disc disease (DDD) (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.

Occipitocervical Plate/Rod/Occipital Screws/Hooks:  Occipitocervical plate, rods, occipital screws, and hooks are intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the occipitocervical junction and the cervical spine. When used to treat occipitocervical and cervical conditions, the occipital screws are limited to occipital fixation only. The occipital screws are not intended for the cervical spine.

Hooks and Rods: Hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

Thoracic Screws: The use of thoracic screws is limited to placement in T1-T3 for anchoring the construct only. The thoracic screws are not intended to be placed in the cervical spine.

Rod Connectors: The Virage OCT Spinal Fixation System can also be linked to the Instinct® Java® Spinal System and Sequoia® Pedicle Screw System offered by Zimmer Spine using rod connectors and transition rods.

The titanium Songer® Spinal Cable System to be used with the Virage OCT Spinal Fixation System allows for cable attachment to the posterior cervical or thoracic spine.

Contraindications

The Virage System is not designed or sold for any use except as indicated. DO NOT USE THE VIRAGE SYSTEM IMPLANTS IN THE PRESENCE OF ANY CONTRAINDICATION. Contraindications include, but are not limited to:

  1. Overt infection or distant foci of infections.
  2. Local inflammation, with or without fever or leukocytosis.
  3. Pregnancy.
  4. Morbid obesity.
  5. Rapid joint disease, bone absorption, osteopenia, and/or osteoporosis.
  6. Suspected or documented metal allergy or intolerance.
  7. Any time implant utilization would interfere with anatomical structures or expedited physiological performance, such as impinging on vital structures.
  8. Severe comminuted fractures such that segments may not be maintained in satisfactory proximate reduction.
  9. Use in displaced, non-reduced fractures with bone loss.
  10. The presence of marked bone absorption or severe metabolic bone disease that could compromise the fixation achieved.
  11. Poor prognosis for good wound healing (e.g., decubitis ulcer, end-stage diabetes, severe protein deficiency, and/or malnutrition).
  12. Any case not needing a bone graft or fusion.
  13. Any case not described in the indications.

Warnings and Precautions

Following are specific warnings, precautions, and adverse effects associated with use of the Virage 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 Virage 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.
  • The Virage 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.
  • 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.
  • 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 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. See DESCRIPTION section for Virage System materials and compatibility information.

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 plate or rods.
  • Bending plate outside of bend zone groove may result in cracking of plate. Surgeon should always inspect plate before implanting.
  • Occiput and pedicle bone integrity should be verified
  • Care should be taken during occiput and pedicle preparation to avoid penetrating too deep.
  • Care should be taken to ensure occipital screw is not driven in 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 Virage 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.

Possible 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.

Possible neurologic operative/postoperative adverse reactions that may require medical or surgical intervention (e.g., implant removal with or without re-instrumentation) include:

  • Paralysis, complete or incomplete. Delayed onset has occurred even when evoked potential was unaffected during surgery
  • Dural tear leading to cerebrospinal fluid fistula or pseudo meningocele
  • Other spinal cord injuries not otherwise described due to positioning of the spinal attachment device
  • Laminar erosion
  • Epidural bleeding
  • Abnormal sensations
  • Radiculopathy

Possible device postoperative complications/adverse reactions that may require medical or surgical intervention (e.g., implant removal with or without re-instrumentation) include:

  • Loosening, bending, breaking, disassembly, and/or migration of the components
  • Collapse of a fracture and/or fusion site
  • Device failure
  • Corrosion at the screw/locking cap interface contributing to breakage, and/or pseudoarthrosis
  • Discomfort or pain, soft tissue erosion, or protrusion due to prominent implanted hardware
  • Attachment device pullout, especially with short constructs and osteoporotic bone
  • Implant or graft extrusion through the skin
  • Postural deformities, pain, skin breakdown, or residual neural compression due to kyphosis or lordosis occurring at the top of the segment being instrumented
  • Bone loss or fracture due to stress shielding
  • Foreign body reaction to the device including tumor formation, autoimmune disease, metallosis, and/or scarring
  • Non-union or pseudoarthrosis
  • Cessation of growth at the fusion site
  • Discitis, arachnoiditis, and/or other types of inflammation

Possible general or local postoperative complications/adverse reactions that may require medical or surgical intervention (e.g., implant removal with or without re-instrumentation) include:

  • Hemothorax
  • Deep vein thrombosis, thrombophlebitis, and/or pulmonary embolism that may be fatal; may be due to patient position and/or length of the surgical procedure
  • Decubitus ulcer
  • Wound infection, deep or superficial, which may require implant removal and/or other medical interventions
  • Wound dehiscence, delayed wound healing, or hematoma
  • Pain, possibly severe in nature
  • Urinary tract infection

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