MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
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Catalog Number 7510600 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Weakness (2145); Ambulation Difficulties (2544); Patient Problem/Medical Problem (2688)
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Event Type
Injury
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Event Description
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It was reported that the patient underwent a spinal fusion procedure at t8-t10 using rhbmp-2/acs on (b)(6) 2012.Patient's post-operative period by initial relief followed by increasingly severe pain and weakness in her lower back and lower extremities.Patient continues to experience severe and unrelenting low back pain that radiates into her lower extremities, and impedes her ability to ambulate, sit and stand.She currently requires the assistance of a walker.
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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.Products from multiple manufacturers 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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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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