MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
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Catalog Number 7510800 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Neuropathy (1983); Stenosis (2263)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).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.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) 2002, patient presented with following pre-operative diagnosis: l4-l5 pseudoarthrosis.For which he underwent following procedures: l4 to l5 posterior nonsegmental transpedicular instrumentation.Posterior spinal fusion l4 to l5.As per op- notes ¿cancellous hydroxyapatite crystals and rhbmp-2 were placed over the re-decorticated transverse process of l4 and l5.¿ patient tolerated the overall procedure without any complications." post-operatively the patient was observed with stenosis at l3-4 and reported lumbar radiculopathy for which the patient underwent a revision surgery at (b)(6) 2010.
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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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