Owi: bone fixation cerclage, sublaminar.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 scoliosis; and underwent spinal fusion, sagittal re-alignment and derotation.Intra-op, during curve correction, while tensioning the tether, the instrument started damaging the tissue of the tether; hence, the physician had to stop applying tension.Then, the damaged distal part of the tether was cut and removed.The broken part did not remain inside the patient.Reportedly, a very good correction of the scoliotic curve could not be performed due to this event; however, no patient complications were reported.
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