Rig®-ZP (Zero Profile Cervical cage)
About
The Zero-Plate construct sits entirely within the interbody space to minimize contact with the esophagus. The two screws that engage the vertebral endplates and provide adequate fixation while facilitating an efficient surgical procedure.
Each screw is prevented from backing out by a locking mechanism resulting in a secure locking mechanism. Other features of the Rig®-ZP system include precise anatomical fit, very large graft windows for maximum fusion area.
Features
No added anterior profile
Angled and flexible instrumentation
Large graft volume
Optimized screw angulations
Self-locking screws
Adaptive sizing
When to use?
Indications
The Rig®-ZP system is a stand-alone cervical fusion device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3–T1) at one level.
DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies.
These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment.
The Rig®-ZP device is to be filled with autogenous bone graft material, and is to be used with titanium alloy screws which accompany the implant.
Contraindications may be absolute or relative. Circumstances below may reduce the chances of a successful outcome:
Contra-Indications
Allergy to PEEK, titanium or cobalt chrome alloys, or foreign body sensitivity. Where material sensitivity is suspected, appropriate tests should be made prior to implantation.
Known or suspected infection/immune system incompetence. Acute or chronic infectious diseases of any etiology or localization.
Any abnormality present which affects the normal process of bone remodeling including, but not limited to, severe osteoporosis involving the spine, bone absorption, osteopenia, active infection at the site, or certain metabolic disorders affecting osteogenesis.
Morbid Obesity. An overweight or obese patient can produce loads on the spinal system, which can lead to failure of the fixation of the device or failure of the device itself.
Any neuromuscular deficit which places an unusually heavy load on the device during the healing period.
Open Wounds
Pregnancy
Any other medical or surgical condition which would preclude the potential benefit of spinal surgery, such as the presence of congenital abnormalities, elevation of sedimentation rate unexplained by other diseases, elevation of the white blood cell (WBC) count or a marked left shift in the WBC differential count.
Any case requiring the mixing of components from two different systems.
Any case requiring the mixture of stainless steel with titanium or stainless steel with cobalt chrome implant components.
Fever or leukocytosis.
Signs of local infection or inflammation.
Previous history of infection.
Prior fusion at the level to be treated.
Alcoholism or heavy smoking.
Senility, mental illness or substance abuse, of a severity that the patient may ignore certain necessary limitations and precautions in the use of the implant, leading to failure or other complications.
Any patient unwilling to follow postoperative instructions.
Inadequate tissue coverage over the operative site.
Note: The above list is not exhaustive.