This device is not approved for sale in us but a similar device with catalog# 1553201035, 510k# k113174 and upn (b)(4) is approved for sale in us.Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.X-ray review: post-op x-rays for t8-sacrum fusion show a persistent deformity in the sagittal and coronal planes.There is a bilateral rod fracture at the inferior aspect of the construct.Fusion status is unknown.If information is provided in the future, a supplemental report will be issued.
|
Pre-operative diagnosis of initial surgery: degenerative lumbar kyphoscoliosis (t9/s2) procedure used in the initial surgery: thoracolumbar vertebra posterior fusion pre-operative diagnosis for revision: reinforcement was performed with 4 rods due to rod breakage (t9/s2) it was reported that the patient underwent a fusion surgery due to degenerative lumbar kyphoscoliosis using rods.Post-op, the rods at both sides of l3/l4 level broke.Additional surgery was performed as a result of the event.The rod of the caudal side was removed and replaced by a new rod.Part of the broken rod was left as it was, and reinforcement was performed with 4 rods.No patient complications were reported as a result of the event.
|