MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
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Catalog Number 7510400 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Ossification (1428); 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 spinal fusion surgery at l5 - s1 using rhbmp-2/acs with posterior approach.Reportedly, sometime post-op, the patient developed osteophytes and/or a lateral calcified disc protrusion of the l5-s1 disc interspace compressing and deteriorating the s1 nerve root.The patient continued to experience severe and unrelenting back pain.
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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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