MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
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Catalog Number 7510200 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Incontinence (1928); Pain (1994); Ambulation Difficulties (2544)
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Event Type
Injury
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Event Description
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It was reported that a patient underwent a posterolateral fusion surgery from l4 to s1 on (b)(6) 2011 using rhbmp-2/acs.The rhbmp-2/acs was placed in the lateral gutters.Sometime postop, the patient reportedly experienced burning pain that shoots down both legs.The patient continues to experience severe and unrelenting back pain and associated numbness that radiates into her lower extremities.She has difficulty urinating as well as trouble walking for extended periods.
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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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