Other: transverse process fracture.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 the patient presented with kyphosis; and underwent thoraco-lumbar vertebral posterior fixation.In this surgery, the pedicles were thin, and the plan was to place transverse process hooks (wide blade hooks) at t4 and t5.The medium sized hooks were chosen by trial.When the actual hooks were placed at t5, the transverse process on both sides fractured; and the hooks could no longer be placed.As hooks were already placed at t4, hook placement at t5 was skipped.This had no impact on the operation, which was completed successfully.No other patient complications were reported other than transverse processes fracture as a result of this event.
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