This part is not approved for use in the united states; however a like device catalog # 5541113, 510k #k132471 and udi # (b)(4) was cleared in the united states.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.
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It was reported that on (b)(6) 2018, 2-2 fusion was performed due to t12 pseudarthrosis, post-op, due to t10 screw backed out, paste was injected after removing the t10 screw and the hooks were placed at t6-8 and connection was performed with connectors lengthwise on (b)(6) 2018.Post-op, the bones (transverse process) stuck together with the hooks and these were cut out and backed out.Revision was scheduled for removal.
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