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 Problem
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 the patient underwent unspecified surgery.Post-op, patient suffered from pain.Patient has left si joint replacement.After it was inserted patient reportedly suffered with a whole new level of pain.The wound dehiscence.Patient developed septic and ards.The foot long wound in the left thigh healed after a few hosp stays requiring both inpatient and outpatient iv therapy and hyperbaric chamber treatment.The pain was worse then patient ever experienced.Patient left leg had no reflexes, it just dangled.The revision surgery was performed.Both lumbar surgery and si joint surgery were done.
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Search Alerts/Recalls
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