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); Loss of Range of Motion (2032); Burning Sensation (2146)
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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.
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Event Description
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Procedure: fusion it was reported that: on an unknown date in (b)(6) 2009 the patient underwent another surgery for installation of hardware on lumbar spine using rhbmp-2.Post-op, the patient lost a significant amount of flexibility, and now suffers from constant burning and stabbing pains in his back.Patient's pain continues to increase, and has now radiated into his neck and legs from his lower back.
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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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