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 Type
Injury
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Manufacturer Narrative
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The product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.X-ray review result: post-op x-ray for t12-l1 lateral discectomy and fusion with interbody graft is provided.Hardware placement is appropriate.There is no apparent hardware malfunction.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 per social media post (dated (b)(6) 2018) that on (b)(6) 2007, patient underwent spinal fusion using rhbmp-2/acs.Po st-operatively, the patient alleged unspecified injury due to the use of rhbmp-2/acs.
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Search Alerts/Recalls
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