(b)(6).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.If information is provided in the future, a supplemental report will be issued.
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It was reported that the patient underwent the following procedures: posterior t7-t9 laminectomy fusion, re-do l4-s1 laminectomy, revision fusion, pseudoarthrosis, re-do l4-5, l5-s1 interbody fusion, ssep in which rhbmp-2/acs was used.Post-op,the patient sustained unspecified injuries following the use of rhbmp-2/acs.
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