No product has been returned for evaluation.No allegation of product failure observed.Review of the radiographs and alleged report indicate confirmation of proper placement as well as symptom relief was achieved.Review also describes the placement of another manufacturer's posterior fixation involving some form of applied compression end resulted in cage movement and subsequent screw breach.Post revision screw removal the patient is reported to be doing well.Labeling review: ".Insert centering pin into midline (fig.2).Use a/p fluoro to verify midline and lateral fluoro to check depth (fig.3).The length of the centering pin is 20 mm." ".When implant is in proper position, select desired hex handle (straight or t) and awl (straight or angled) and place over the proximal end of awl shaft.Once awl is secured, set awl depth stop to zero and place into desired guide tube and bolt pocket.When the awl is bottomed out in the bolt pocket, select 15 mm awl depth on depth stop and proceed to deploy awl.Awl will deploy at nominal cranial/caudal bolt trajectory of 35°.Confirm proper depth and trajectory on lateral fluoro imaging.Awl is fully seated into bolt hole when green fluorescent color band on distal end of awl disappears into guide tube." ".Potential risks identified with the use of this system, which may require additional surgery, include: · bending, fracture or loosening of implant component(s) · loss of fixation · nonunion or delayed union · fracture of the vertebra · neurological, vascular or visceral injury · metal sensitivity or allergic reaction to a foreign body · infection · decrease in bone density due to stress shielding · pain, discomfort or abnormal sensations due to the presence of the device" ".Compatibility: do not use base interfixated system with components of other systems.Unless stated otherwise nuvasive devices are not to be combined with the components of another system." ".It is important to select the appropriate length base interfixated screw and confirm trajectory under intraoperative fluoroscopy in order to avoid potential screw impingement.".
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