MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
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Catalog Number 7510800 |
Device Problem
Insufficient Information (3190)
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Patient Problem
Injury (2348)
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Event Type
Injury
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Event Description
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It was reported that the patient developed unspecified injuries following the use of rhbmp-2/acs in an unspecified spinal fusion surgery.No additional information was reported.
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Event Description
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It was reported that on (b)(6) 2006 the patient underwent a fusion procedure in which rhbmp-2/acs, cages, cancellous crushed chips, and blackstone medical inc¿s unity s1, cover s1, screws, rods and set screws were used.
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Manufacturer Narrative
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(b)(4).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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Manufacturer Narrative
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(b)(4).
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Search Alerts/Recalls
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