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
Scarring (2061); Ambulation Difficulties (2544)
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Event Type
Injury
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Manufacturer Narrative
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(b)(6).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 patient underwent unspecified surgery involving rhbmp-2.Patient was not sure if it was a cervical surgery.Post-op, when patient went to reach for things, or walk, patient felt very weird.Patient was diagnosed with multiple sclerosis on (b)(6) 2015.Patient had a scar on her neck that wouldn¿t heal.
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Search Alerts/Recalls
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