MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
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Catalog Number 7510800 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Death (1802); Ambulation Difficulties (2544)
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Event Type
Death
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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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Event Description
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It was reported that on: (b)(6) 2006, the patient presented for spinal fusion procedure using bmp.Reportedly, following the surgery the patient developed a brain tumor.The brain tumor caused the patient to have trouble walking and he developed stroke like symptoms where he could not lift his arm and his face began to droop.Reportedly, the patient underwent chemotherapy and eventually had to have a temporal lobectomy in an attempt to remedy his injuries.It was reported that on or about (b)(6) 2008 the patient died from his injuries.
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Search Alerts/Recalls
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