Product complaint #: (b)(4).This complaint was generated from literature review conducted in post market surveillance (pms) for health authority reporting purposes.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the pms identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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This report is being filed after the subsequent review of the following literature article: rigid occipitocervical fixation: indications, outcomes and complications of the modern era.Robin bhatia, ph.D., f.R.C.S.(sn), ruth m.Desouza, m.R.C.S., jonathan bull, f.R.C.S.(sn), and adr ian t.H.Casey, f.R.C.S.(sn) department of neurosurgery, the national hospital for neurology and neurosurgery, queen.Broken rod and 1 loose screw, two screw pull out, two broken rods and 1 loose screw, broken rod.
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