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 a correction surgery at t6-l3.Intra-op, after placement was performed, the tethers broke while applying tension with the tensioner.Tension was applied when correction was once performed.After provisional fixation, loosening was performed.And when tension was applied again during the second correction, the tethers broke.Therefore, product from another manufacturer (nesplon) was used.The surgeon wondered whether correction was performed excessively.The broken product was removed with no fragment of the product remaining inside the patient.No patient complications were reported as a result of this event.
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