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
Pain (1994); Tingling (2171)
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Event Type
Injury
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Manufacturer Narrative
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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.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Pre-op diagnosis: degenerative disc disease, herniated discs on (b)(6) 2011, patient underwent a spinal fusion surgery at c5-c6 in which rhbmp-2/acs with instrumentation was implanted.Post-op, patient complained of mid and low back pain with tingling in her legs and toes.
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Search Alerts/Recalls
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