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
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Seroma (2069)
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Event Type
Injury
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Event Description
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It was reported that rhbmp-2/acs was implanted in multiple patients during multi-level posterior cervical fusions.Post-operatively, seromas were discovered in each case.No further information was provided.
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Manufacturer Narrative
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Ages: 35-60 yrs.Pt gender: males and females.Implant date: unknown.(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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Search Alerts/Recalls
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