Pma/510k: this part is not approved for use in the united states; however, a like device with catalog # 55840014530, 510(k) # k113174 and udi # (b)(4) is approved for sale in the us.Neither the device nor applicable imaging films were returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event.If information is provided in the future, a supplemental report will be issued.
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It was reported that the patient presented with ossification of ligamentum flavum; and underwent posterior spinal fusion at t7-t12.On an unknown date, post-op, the screw implanted at t7 loosened.Also, stenosis occurred at the upper level of the fixation range (stenosis was around t5-t6 and t6-t7).Hence, a revision surgery was performed, in which the following procedures were performed: (i) rod and two connectors were removed.(ii) the loose screw at t7 was replaced.(iii) pedicle screw was added to t5-t6.(iv) vertebral body at t12 collapsed a little, and pedicle screw was added to l1.(v) rod placement was performed from t5 to l1.(vi) two connectors were placed.(vii) additional decompression was performed at t5-t6-t7.
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