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 Date 12/07/2009 |
Event Type
Injury
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Manufacturer Narrative
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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.H6: 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 underwent fusion surgery in which rhbmp2/acs was implanted.As per op-notes,¿ after more irrigation and end plate and bone preparation, and more decompression, a 14-mm medium cage was chosen.It was packed with 1 large kit of bmp.It did have good positioning on the ap and lateral fluoroscopy.It was countersunk.Anterior instrumentation was added at l4-5 with an interference screw and washer.Positioning was appropriate again upon check on fluoroscopy¿.The patient tolerated the procedure well without any intraoperative complications.
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