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 Problem
Injury (2348)
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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.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) 2008 the patient underwent: posterior lumbar fusion l4-5; placement of segmental interspinous process plating l4-5; use of morcellized allograft; use of bone morphogenic protein.Pre-operative diagnosis: l4-5 internal disc disruption, mechanical low back pain, annular tear.Per-op notes: ¿we then took morcellized allograft chips and wrapped them up with bmp soaked collagen sponge.We then packed the sponges in the lateral facet joints bilaterally.We then placed the sponge posterior interspinous process instrumentation.¿ on an unknown date post-op, patient alleged unspecified injuries due to use of rhbmp-2/acs.
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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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