INDICATIONS, SAFETY, AND WARNINGS Infinity OCT System

Description

The INFINITY™ OCT System is a posterior occipitocervical-upper thoracic system, which consists of a variety of shapes and sizes of plates, rods, hooks, screws, multi-axial screws, and connecting components, which can be rigidly locked to the rod in a variety of configurations, with each construct being tailor-made for the individual case. The INFINITY OCT System is fabricated from medical grade titanium alloy and medical grade cobalt chromium. Medical grade titanium alloy and medical grade cobalt chromium may be used together. Never use titanium alloy and/or cobalt chromium with stainless steel in the same construct. No warranties, expressed or implied, are made.

Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded. To achieve best results, do not use any of the INFINITY OCT System implant components with components from any other system or manufacturer unless specifically labeled to do so in this or another Medtronic document. As with all orthopedic and neurosurgical implants, INFINITY OCT System components should never be reused under any circumstances. 

Indications

The INFINITY OCT System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7), and the thoracic spine from T1-T3:

• Traumatic spinal fractures and/or traumatic dislocations.
• Instability or deformity.
• Failed previous fusions (e.g. pseudarthrosis).
• Tumors involving the cervical spine.
• Degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.

The INFINITY OCT System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. In order to achieve additional levels of fixation, the INFINITY OCT System may be connected to the CD HORIZON™ Spinal System and VERTEX™ Reconstruction System rods with the INFINITY OCT System rod connectors. Transition rods with differing diameters may also be used to connect the INFINITY OCT System to the CD HORIZON Spinal System. Refer to the CD HORIZON  Spinal System package insert  and VERTEX Reconstruction System package insert for a list of the indications of use. 

Note: The 3.0mm multi axial screw (MAS) requires the use of MAS CROSSLINK™ at each level in which the 3.0mm screw is intended to be used.  

The lateral offset connectors and MAS extension connectors are intended to be used with 3.5mm and larger diameter multi axial screws. The lateral offset connectors and MAS extension connectors are not intended to be used with 3.0mm screws.

Note: Segmental fixation is recommended for these constructs.

Contraindications

Contraindications include:

• Active infectious process or significant risk of infection (immunocompromise).
• Signs of local inflammation.
• Fever or leukocytosis.
• Morbid obesity.
• Pregnancy.
• Mental illness.
• Grossly distorted anatomy caused by congenital abnormalities.
• Any other medical or surgical condition which would preclude the potential benefit of spinal implant surgery, such as the presence of congenital abnormalities, elevation of sedimentation rate unexplained by other diseases, elevation of white blood count (WBC), or a marked left shift in the WBC differential count.
• Suspected or documented metal allergy or intolerance.
• Any case not needing a bone graft and fusion.
• Any case where the implant components selected for use would be too large or too small to achieve a successful result.
• Any patient having inadequate tissue coverage over the operative site or inadequate bone stock or quality.
• Any patient in which implant utilization would interfere with anatomical structures or expected physiological performance.
• Any patient unwilling to follow postoperative instructions.
• Any case not described in the indications.

Nota bene: although not absolute contraindications, conditions to be considered as potential factors for not using this device include:

• Severe bone resorption.
• Osteomalacia.
• Severe osteoporosis.