This report is being filed after the review of a clinical evaluation report (cer) from a related research activity database (ddra) for patients undergoing spinal decompression, fusion, rigid stabilization, and motion preserving stabilization.Failed spinal decompression, fusion, rigid stabilization, and motion preserving stabilization has been identified as per spine tango registry report experienced by the following with corresponding intervention: 19 patients had general complications - intraoperative: anaesthesiological (4), cardiovascular (4), pulmonary (1), thromboembolism (1), other (4), not documented (5).149 patients had general complications - postoperative surgical before discharge: cardiovascular (15), pulmonary (30), cerebral (8), kidney / urinary (25), liver / gi (16), thromboembolism (6), death (7), other (30), not documented (12).109 patients had surgical complications - intraoperative adverse events: nerve root damage (4), dural lesion (85), vascular injury (3), fracture vertebral structures (1), other (12), not documented (4).164 patients had surgical complications - postoperative surgical before discharge: epidural hematoma (7), other hematoma (13), radiculopathy (8), csf leak / pseudomeningocele (11), motor dysfunction (25), sensory dysfunction (16), bowel / bladder dysfunction (7), wound infection superficial (16), wound infection deep (14), implant malposition (15), implant failure (2), other (18), not documented (12).93 patients had reoperations at any level due to adjacent segment pathology (17), failure to reach therapeutic goals (9), hardware removal (17), implant failure (18), implant malposition (2), instability (11), neurocompression (7), non-union (9), other (4), postoperative infection deep (2), sagittal imbalance (2), unknown (53); 38 patients had reoperations at the same level due to adjacent segment pathology (3), failure to reach therapeutic goals (3), hardware removal (5), implant failure (7), implant malposition (1), instability (2), neurocompression (3), non-union (4), other (1), postoperative infection deep (1), unknown (23).This is for depuy spine expedium and viper pedicle screw systems.This report is for one (1) unknown mono/polyaxial screw.This is report 6 of 6 for (b)(4).
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