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
Neuropathy (1983); Pain (1994); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4) (persisting back pain), (b)(4) (revision surgery).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.Although it is unknown if the device contributed to the reported event, we are filing this mdr for notification purposes.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that on (b)(6) 2014, patient underwent spine fusion surgery from vertebrae l4 to s1.Reportedly, the patient was implanted with rhbmp-2/acs in this surgery.The rhbmp-2 collagen sponge was used to fuse more than one level of the spine.The rhbmp-2 collagen sponge was placed outside a cage (in the disc space and over the posterior elements).Allegedly, patient's post-operative period has been marked by a period of improvement, followed by progressively worsening low back pain and left lower extremity radiculopathy.The patient continued to experience sever pain that radiates into her lower extremities.
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Manufacturer Narrative
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A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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