MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
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Catalog Number 7510400 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
Injury
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Event Description
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It was reported that the patient underwent an unspecified fusion procedure using rhbmp-2/acs, 14 mm plate, 13 mm peek ar spacer, 26 mm screws and dbx mix 10 cc.Vessel guard was also used during the procedure.
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Manufacturer Narrative
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(b)(4): neither device nor applicable imaging studies returned to manufacturer for evaluation.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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