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
Neuropathy (1983); Pain (1994); Swelling (2091); Tingling (2171); Numbness (2415); Ambulation Difficulties (2544)
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Event Type
Injury
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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.Multiple products 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) 2016 ,the patient underwent revision fusion surgery on the thoracolumbar region of her spine from vertebrae t3 to s1 due to pain.The rhbmp-2 collagen sponge was placed outside a cage i.E., in the posterior elements.Patient continued to experience 새ronic lower back pain, with pain radiating down to her hips and legs, numbness and tingling in her right buttock, and swelling at the surgical site and in her ankles and feet.The patient uses a cane to assist in ambulation.".
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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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