This part is not approved for sale in the us but a similar part with catalogue# 1476200500 and 510k# k132111 and udi# (b)(4) is approved for sale in the us.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.If information is provided in the future, a supplemental report will be issued.
|
Type of procedure: fixation was performed at t9-s2 with s4.It was reported that on (b)(6) 2018, post-op, the rod was found to be broken near l1.Hence, on (b)(6) 2018, a revision surgery was performed, in which the broken rod was connected with 4 connectors (in total) on the left and right side.Then, a new rod was inserted for reinforcement.
|