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 Problems
Dysphagia/ Odynophagia (1815); Nerve Damage (1979); Patient Problem/Medical Problem (2688)
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Event Type
Injury
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Event Description
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It was reported that the patient underwent a cervical fusion surgery on (b)(6) 2003 using rhbmp-2/acs.On (b)(6) 2004 the patient underwent an unspecified surgery.On (b)(6) 2012 the patient underwent another unspecified surgery using rhbmp-2/acs.At an unknown time post-op, the patient experienced complications including dysphagia, nerve damage, and speaking issues.
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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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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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