Correction: product code updated to nkb.Common device name update to thoracolumbosacral pedicle screw system.Method: x-ray review, nc/capa history review, labelling review, risk assessment result: the customer reported event was confirmed via x rays.The device is still implanted in the patient therefore, device evaluation could not be performed.Lot # has not been provided , therefore, product history review could not be performed.X rays provided show the rods slipped out of the closed head screws.An anti- torque was not used during procedure.There were zero intraoperative complications.Unknown post op activity and if the patients fell.Conclusion: as stated in the ifu patient post op activity, patient fall and length of implantation could have also contributed to the event.Additionally, not using anti torque when tightening down the blocker could have contributed as it could result in too much torque being applied to the set screw, possibly deforming it and reducing the surface area contacting the rod holding it in place.However, as the device is still implanted, a definite root cause cannot be confirmed without evaluating the devices.Device still in the patient.
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