MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
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Catalog Number UNKNOWN |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Muscle Spasm(s) (1966); Pain (1994); Paralysis (1997)
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Event Type
Injury
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Event Description
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It was reported by the patient on a website article that the patient underwent a procedure for lumbar fusion with hardware and rhbmp-2 following a motor vehicle accident.After trying a course of injections which did not relieve leg pain, the patient's neurosurgeon recommended a lumbar fusion.Sometime after the procedure, the patient reported that he fell off his shower chair causing the implanted hardware to shift into his nerve root.The patient was taken to the emergency room and a ct scan revealed a bulged disc and shifted bone graft that would require an additional surgery.The article notes that at 45 days post-op the patient underwent an additional surgery after the screws shifted.Patient states that the surgery never relieved his leg pain."my right leg sometimes gives out completely and i can¿t even feel it for a few seconds - it is actually paralyzed." pt.Is taking diazepam for muscle spasms and oxycontin for pain.Pt.Is scheduled for implant of a nerve stimulator.
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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.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.
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