(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.Multiple products 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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It was reported that on (b)(6) 2014, patient underwent anterior cervical discectomy and fusion- extralaryngeal anterolateral approach to treat degenerative disc disease at levels c4-c5, c5-c6 where rh-bmp2 was implanted.Post-op, the patient had the following adverse events: on (b)(6) 2014, patient presented with pre-op diagnosis of variety of sensations in neck and upper back including sparks, twinges, knots, often associated with headache; symptoms wax and wane for >12 months; eventually attributed to post-laminectomy.On (b)(6) 2015, patient underwent diagnostic test: mri without contrast, cervical spine, diagnostic results: abnormal, disc herniations, c3-4, c6-7.Other actions included physical therapy referral to specialist, specify: interventionist for trigger point injections, cervical epidural blocks.The event is not related to surgical procedure.
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