MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Injury (2348)
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Event Type
Injury
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Manufacturer Narrative
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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.Products from multiple manufacturers were implanted during the procedure.Although it is unknown if any of the devices contributed to the reported event, we are filing this mdr for notification purposes.
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Event Description
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It was reported that on: (b)(6) 2008: the patient was pre-operatively diagnosed with l5-s1 lumbar herniated disk, back pain status post microscopic discectomy l5-s1 and underwent the following procedures: l5-s1 lumbar laminectomy.The l5-s1 posterior lumbar interbody fusion.The l5-s1 application of intervertebral body device.Posterior spinal fusion.The l5-s1 application of posterior spinal instrumentation.The l5-s1 application of rhbmp-2/acs bone graft with local autologous bone grafting.No intra-operative complications were reported.
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Search Alerts/Recalls
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