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
Ossification (1428); Neuropathy (1983); Pain (1994)
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Event Type
Injury
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Event Description
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It was reported that the patient underwent l5-s1 partial vertebrectomy and l5-s1 re-fusion in which rhbmp-2/acs was used.Reportedly, sometime post-op, imaging studies showed that the patient had developed uncontrolled bone growth and nerve compression at or near where the rhbmp-2/acs was implanted.The patient experienced chronic pain and radiculitis.
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Manufacturer Narrative
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(b)(4).Neither the device nor applicable imaging study films or patient medical records 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/used 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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Search Alerts/Recalls
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