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Zimmer, Inc.

Veyron-C™ Anterior Cervical System

Product Description

The Veyron-C System is a two-screw, stand-alone ACDF device with a titanium-plasma coating designed to increase primary stability and deliver sufficient bone integration for a secure fusion.

 Features

  • Designed for Stability: Titanium-plasma coating on the PEEK spacer provides fluoroscopic endplate visualization and large graft area supports a superior healing environment.
  • Designed for Procedural Simplicity: integrated endoskeleton surrounded by outer PEEK ring is designed to promote increased torsional strength and shear performance. Groove on plate face facilitates inserter attachment and implant placement. Lordotic and parallel options.
  • One-Step Secure Locking Mechanism: Provides tactile and visual feedback and prevents screw migration, facilitating a secure surgical procedure.

ZS-SA0700-45_A

Device Description

The Veyron-C Anterior Cervical System is a stand-alone intervertebral fusion device used to restore biomechanical height and to act as an aid in fusion of the cervical spine in anterior discectomy procedures. The spacer is generally box-shaped with teeth on the superior and inferior surfaces of the device, and is manufactured either from titanium alloy (Ti6AI4V) in accordance with ASTM F136 and Invibio PEEK Optima LT1 in accordance with ASTM F2026, or from Ti6Al4V titanium alloy alone.  The spacer may optionally have the teeth plasma coated with medical-grade titanium per ASTM F1580. The spacer is secured in location through the use of Ti6Al4V titanium alloy bone screws. The implants are provided in various sizes and lengths to adjust for variations in patient anatomy.

Indications

The Veyron-C Anterior Cervical System is a stand-alone cervical intervertebral fusion device intended for spinal fusion procedures at one level (C3 – T1 inclusive) in skeletally mature patients for treatment of degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).  Implants are to be implanted via an open, anterior approach and packed with autogenous bone graft.  Patients should receive at least six (6) weeks of non-operative treatment prior to treatment with a cervical intervertebral fusion device.

Contraindications

Contraindications for the Veyron-C Anterior Cervical System are similar to those of other systems of similar design, and include, but are not limited to:

  1. Patients with probable intolerance to the materials used in the manufacture of this device.
  2. Patients with infection, inflammation, fever, tumors, elevated white blood count, obesity, pregnancy, mental illness and other medical conditions which would prohibit beneficial surgical outcome.
  3. Patients resistant to following post-operative restrictions on movement, especially in athletic and occupational activities.
  4. Use with components from other systems or manufacturers.
  5. Grossly distorted anatomy caused by congenital abnormalities.
  6. Any other medical or surgical condition which would preclude the potential benefit of spinal implant surgery.
  7. Rapid joint disease, bone absorption, osteopenia. Osteoporosis is a relative contraindication since this condition may limit the degree of obtainable correction, stabilization, and/or the amount of mechanical fixation.
  8. Any case where the implant components selected for use would be too large or too small to achieve a successful result.
  9. Any patient having inadequate tissue coverage over the operative site or inadequate bone stock or quality.
  10. Any patient in which implant utilization would interfere with anatomical structures or expected physiological performance.
  11. Any case not described in the indications for use.
  12. Reuse or multiple uses.
  13. Prior fusion at the level(s) to be treated.

 See also the WARNINGS, PRECAUTIONS and POSSIBLE ADVERSE EFFECTS section.

WARNINGS, PRECAUTIONS AND POSSIBLE ADVERSE EFFECTS

Warnings and Precautions

As with any surgical system, the Veyron-C Anterior Cervical System should only be used by experienced surgeons with specific training in the use of this spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.

Knowledge of surgical techniques, proper selection and placement of implants, and pre- and post-operative patient management are considerations essential to a successful surgical outcome.  Appropriate selection, placement and fixation of the spinal system components are critical factors which affect implant service life.  As in the case of all prosthetic implants, the durability of these components is affected by numerous biologic, biomechanics and other extrinsic factors, which limit their service life.  Accordingly, strict adherence to the indications, contraindications, precautions, and warnings for this product is essential to potentially maximize service life.  (Note: While proper implant selection can minimize risks, the size and shape of human bones present limitations on the size, shape, and strength of the implants).

Patients who smoke have been shown to have an increased incidence of pseudoarthrosis.  Such patients should be advised of this fact and warned of the potential consequences.  Patients with previous spinal surgery at the level to be treated may have different clinical outcomes compared to those without a previous surgery.  Based on the fatigue testing results, the physician/surgeon should consider the level of implantation, patient weight, patient activity level, and other patient conditions, etc. which may have an impact on the performance of the system.

If the patient is involved in an occupation or activity which applies inordinate stress upon the implant (e.g. substantial walking, running, lifting, or muscle strain) resultant forces can cause failure of the device. In some cases, progression of degenerative disease may be so advanced at the time of implantation that the expected useful life of the appliance may be substantially decreased.  In such cases, orthopedic devices may be considered only as a delaying technique or to provide temporary relief. Patients should be instructed in detail about the limitations of the implants, including, but not limited to, the impact of excessive loading through patient weight or activity, and be taught to govern their activities accordingly.  The patient should understand that a metallic implant is not as strong as normal, healthy bone and will bend, loosen or fracture if excessive demands are placed on it.  An active, debilitated, or demented patient who cannot properly use weight supporting devices may be particularly at risk during postoperative rehabilitation.

Mixing Metal; some degree of corrosion occurs on all implanted metal alloys. Contact of dissimilar metals, however, may accelerate this corrosion process. The presence of corrosion may accelerate fatigue fracture of implants, and the amount of metal compounds released into the body system will also increase. Internal fixation devices, such as rods, hooks, screws, etc. which come in contact with other metal objects, must be made from like or compatible metals. Because different manufacturers employ different materials, varying tolerances and manufacturing specifications, and differing parameters, the components of Veyron-C should not be used in conjunction with components from any other manufacturer’s spinal system.

Care must be taken to protect the components from being marred, nicked or notched as a result of contact with metal or abrasive objects.  Alterations will produce defects in surface finish and internal stresses which may become the focal point for eventual breakage of the implant.

As with all orthopedic and neurosurgical implants, none of the Veyron-C Anterior Cervical System components should ever be reused under any circumstances.  Risks associated with reuse include infection, non-union (pseudarthrosis), serious patient injury or death.

Due to the presence of implants, interference with roentgenographic, CT and/or MR imaging may result.  The Veyron-C Anterior Cervical System has not been evaluated for safety and compatibility in the MR environment.  The Veyron-C Anterior Cervical System has not been tested for heating or migration in the MR environment.  The materials used in the manufacture of the Veyron-C Anterior Cervical System have an established safety profile with respect to compatibility, heating and migration in the MR environment.  However, it must be noted that there are several different manufacturers and generations of MRI systems available, and Zimmer Spine cannot make any claims regarding the safety of Zimmer Spine implants and devices with any specific MR system.

Physician Note: The physician is the learned intermediary between the company and the patient. The indications, contraindications, warnings, and precautions given in this document must be conveyed to the patient.  If requested, additional information, including surgical technique manuals, may be obtained through corporate sales representatives.

Possible Adverse Effects

Potential complications and adverse effects for this system are similar to those of other spinal instrumentation systems, and include, but are not limited to:

  1. Early or late loosening of any or all of the components.
  2. Disassembly, bending, and/or breakage of any or all of the components.
  3. Foreign body (allergic) reaction to implants.
  4. Post-operative change in spinal curvature, loss of correction, height, and/or reduction.
  5. Infection.
  6. Dural tears, persistent CSF leakage, meningitis.
  7. Loss of neurological function including paralysis (partial or complete), radiculopathy, and/or the development or continuation of pain, numbness, spasms, or sensory loss.
  8. Cauda equina syndrome, neurological deficits, paraplegia, reflex deficits, irritation, and/or muscle loss.
  9. Loss of bladder control or other types of urological system compromise.
  10. Scar formation possibly causing neurological compromise or compression around nerves and/or pain.
  11. Fracture, micro-fracture, resorption, damage, or penetration of any spinal bone.
  12. Herniated nucleus pulposus, disc disruption or degeneration at, above, or below the level of surgery.
  13. Non-union (pseudarthrosis), delayed union, mal-union.
  14. Cessation of any potential growth of the operated portion of the spine.
  15. Loss of or increase in spinal mobility or function.
  16. Inability to perform the activities of daily living.
  17. Death.