MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
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Catalog Number 7510200 |
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: cervical stenosis c4-c5 and c5-c6.The patient underwent the following procedures: anterior cervical diskectomy and fusion with plating, c4-c5 and c5-c6 using rhbmp-2/acs.No intra-operative complications were reported.
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Search Alerts/Recalls
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