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.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that the patient presented with the following pre-op diagnosis: post spinal fusion and instrumentation from the l2-l4 level with persistent back pain and underwent fusion surgery in which rhbmp2/acs was used.As per operative notes, ¿copious amounts of irrigation irrigated through the wound and dissection was carried on down to the transverse processes at: l2, l3 and l4 and transverse processes were decorticated.Local autograft supplemented with bone morphogenic protein soaked sponge wrapped around the allograft was impacted in the posterolateral region predominantly on the right side for the posterior fusion part of the procedure¿.No intra-operative complications were reported.
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Search Alerts/Recalls
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