It was reported that the patient underwent a fusion procedure using rhbmp-2/acs on (b)(6), 2011.Patient's post-operative period has been marked by severe low back pain and numbness in her lower extremities.An mri scan conducted on (b)(6), 2012, revealed a neurocompressive lesion at the implant site.On (b)(6) 2012, patient's surgeon performed a revision surgery.Patient continues to experience severe and unrelenting lower back pain and weakness that radiates into her lower extremities.She is unable to stand for extended periods, and has difficulty working, walking, and being active.She now also suffers from incontinence.
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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.Products from multiple manufacturers 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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