7200902

Indications, Safety, and WarningsAtlantis Vision™ Elite anterior cervical plate components are intended for anterior interbody screw fixation of the cervical spine during the development of a cervical spinal fusion.DescriptionThe Atlantis™ anterior cervical plate system consists of a variety of shapes and sizes of bone plates (set screws and washers are pre-assembled to the plates), screws, and associated instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. Atlantis™ anterior cervical plate system implant components are fabricated from titanium alloy, with certain plates having subcomponents manufactured from shape memory alloys
(nitinol-NiTi). Stainless steel and titanium implant components must not be used together in a construct. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded. Do not use any of the Atlantis™ anterior cervical plate system components with the components from any other system or manufacturer.Indications for useThis system is intended for anterior interbody screw fixation from C2 to T1. Indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with:

DDD — degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)

Trauma (including fractures)

Tumors

Deformity (defined as kyphosis, lordosis, or scoliosis)

Pseudarthrosis, and/or

Failed previous fusions

ContraindiationsContraindications include:

Infection local to the operative site

Signs of local inflammation

Fever or leukocytosis

Morbid obesity

Pregnancy

Mental illness which would prevent the patient from following post operative instructions

Medical or surgical conditions which would preclude the potential benefit of spinal implant surgery, such as the 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

Cases not needing a bone graft and fusion or where fracture healing is not required

Cases requiring the mixing of metals from different components

Patients having inadequate tissue coverage over the operative site or where there is inadequate bone stock, bone quality, or anatomical definition

Cases not described in the indications

Patients unwilling to cooperate with post-operative instructions

Any time implant use would interfere with anatomical structures or expected physiological performance

Rapid joint disease, severe bone resorption, osteopenia, osteomalacia, and/or severe osteoporosis. Osteoporosis is a relative contraindication since this condition may limit the degree of obtainable correction, the amount of mechanical fixation, and/or the quality of the bone graft.

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

Potential adverse eventsAll adverse events associated with spinal fusion surgery without instrumentation are possible. With instrumentation, a listing of potential adverse events includes:

Early or late loosening of components

Disassembly, bending, and/or breakage of components

Foreign body or allergic reaction to implants, debris, corrosion products, graft material (e.g., metallosis, staining, tumor formation, and/or autoimmune disease)

Pressure on the skin from component parts in patients with inadequate tissue coverage over the implant possibly causing skin penetration, irritation, and/or pain

Bursitis and tissue damage caused by improper positioning and placement of implants or instruments

Post-operative change in spinal curvature, loss of correction, height, and/or reduction

Infection

Dural tears

Change of neurological function, including paralysis (complete or incomplete), dysesthesias, hyperesthesia, anesthesia, paraesthesia, appearance of radiculopathy, and/or the development or continuation of pain, numbness, neuroma, or tingling sensation

Neuropathy, neurological deficits (transient or permanent), bilateral paraplegia, reflex deficits, and/or arachnoiditis

Urinary retention, loss of bladder control, or other types of urological system compromise

Scar formation possibly

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