MEDTRONIC SOFAMOR DANEK 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
Failure of Implant (1924); Pain (1994)
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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.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that patient underwent unspecified surgery.Post-op, patient complained chronic pain and the fusion did not take place at s1 ,l5,l4.X-ray states that hardware is stable; screws have not moved.
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Search Alerts/Recalls
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