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) 2010: the patient presented with spinal stenosis and instability at l2-l3.The patient underwent the following procedures: bilateral decompressive laminectomy l2-l3 with medial facectomy and foraminotomy.Neurolysis, l2-l3.Revision of scar, lumbar, greater than 5cm, partial removal of old hardware, instrumented lumbar fusion, l2-l3.Attempted fusion with instrumentation at l2-l3.Interbody fusion with bmp and bone graft.As per op-notes, "the transverse processes and lateral masses at the levels between l2-l3 were debrided.Bmp, graft matrix , patient's own bone and croutons from the anatomical laboratory were placed in place in the lateral masses." no patient complications were reported.On (b)(6) 2011: the patient presented with right-sided empyema.Previous right rib fractures (remote past).Hypertension.Hyperlipidemia.Spinal stenosis.The patient underwent right 6th interspace thoracotomy.Decortication.No patient complications were reported.
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