On an unknown date, surgery for idiopathic scoliosis (type 5) was performed using the expedium system.The fixed area was t10 ¿ l3.A couple of months after the surgery, corrective force was significantly lost and the patient had a lower back pain.The surgeon judged that loss of the corrective force was due to loosening of the set screws.On (b)(6) 2017, re-operation was performed where it was confirmed that five (5) set screws were loosened and two (2) set screws were dislocated.The surgeon took the following procedures during the surgery.Corrected the fixed area again.Replaced the seven (7) set screws (part#: 179702000, lot#: unk) with new ones.Reinforced the area of a possible risk of loosening.The re-operation was successfully completed without any delay.The surgeon experienced this sort of event for the first time, so he would like to know about our opinion based on in-depth investigation.
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The torque wrench handle was returned for evaluation.Visual inspection found signs of superficial wear.Torque testing found the device to be out of specification.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.A trend analysis was conducted.No emerging trends were found requiring further actions.The root cause of the torque handle exerting less torque than intended cannot be determined from the sample and the information provided.A potential root cause may be wear and tear to the device over many uses.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends were found, this complaint file will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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