Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.(b)(4).A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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It was reported that on: (b)(6) 2007: patient presented with following pre-op diagnoses: status post l2-l5 lumbar fusion; diskogenic low back pain l4-s1.For which, patient underwent following procedures: l5-s1 posterior spinal fusion; l5-s1 bilateral lateral recess decompression; l5-s1 posterior lumbar interbody fusion; segmental instrumentation using titanium system; implantation capstone cages x2; local bone graft, allograft bone graft, rhbmp-2/acs; running and triggered emgs; intraoperative ct scan evaluation; intraoperative fluoro navigation.Per op notes, a trial was performed with a 25 x 12 mm in height capsule and cage was implanted into the disk space.Intraoperative fluoroscopy was employed and showed the case to be in satisfactory position.Next, the actual cage was filled with allograft bone graft.Rhbmp2 was placed anterior to the cage and the cage was impacted at the l5-s1 level.An identical procedure was performed on the right side and bilateral cage implantation was obtained.Patient tolerated the procedure well without any intraoperative complications.On (b)(6) 2007: patient presented with following pre-op diagnoses: status post l5-s1 posterior lumbar interbody fusion; interbody cage of migration causing bilateral radiculopathy.For which, patient underwent following procedures: anterior lumbar decompressive diskectomy; removal of capstone cages x2; l5-s1 anterior interbody fusion; implantation precision bone implant times one; implantation infused rhbmp-2/acs; application titanium plate.Per op notes, the implants were identified.These were noted to be grossly loose and eroded into the superior endplate of l5-5.These were hooked with a nerve hook and then gently removed from the disk space.It was agreed that implanting the bone implant flush with the anterior cortex of l5-s1 would provide the greatest support at this level.Good resistance to collapse was evident due to the posterior instrumentation.The implant was filled with rhbmp-2/ acs and then placed into position.The implant was slightly impacted into position and good the anterior support was felt to be obtained.Patient tolerated the procedure well without any intraoperative complications.
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