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
Neuropathy (1983); Pain (1994); Swelling (2091)
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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.Multiple products 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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Event Description
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It was reported that on (b)(6) 2011, the patient underwent an anterior lumbar interbody fusion surgery on the lumbar region of her spine from vertebrae l2 to l5.The rhbmp-2 collagen sponge was used to fuse more than one level of the spine.Post-op the patient allegedly had " increasing pain in her lower back, hips and legs." reportedly, " the patient continues to experience chronic and constant pain and swelling, with pain radiating down to her left buttock, leg and knee, and pain extending up to her mid to upper back.She is limited in mobility, and cannot sit or stand for extended periods.".
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Event Description
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It was reported that on (b)(6) 2011: the patient was pre-operatively diagnosed with lumbar disco genic back pain and underwent the following procedures: arthrodesis anterior interbody technique at l2-3, l3-4, l4-5 with insertion of peek anterior interbody spacers.Anterior instrumentation placement at l2-3,l3-4, l4-5.Anterior lumbar discectomy with decompression of spinal canal at l2-3, l3-4, l4-5 application of rhbmp-2/acs.Application of allograft bone.Local bone grafting.As per op-notes, ¿once good opposition of the end plates was then obtained and a good tight fit was obtained with the trial spacer, the corresponding peek implant was chosen.A 7 degree implant was used at l2-3, 12 degree implants at l3-4 and l4-5 to help restore lordosis.The central cavity was then packed with role of bmp surrounding local bone grafting as well as allograft bone.Once this was packed into the peek implant, this was then inserted into the disk space and impacted in position.Fluoroscopy imaging was utilized during this placement to ensure good overall placement.¿ the patient was also pre-operatively diagnosed with lumbar disc disease at l2-l3, l3-l4 and l4-l5 and underwent anterior exposure of lumbar spine at l2-l3, l3-l4 and l4-l5.
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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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