Method: x-ray image review, nc/capa history review, labelling review, risk assessment result : the 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.It was reported that patient was obese and anti torque not used.Post-op activity of the patient is unknown.Conclusion: as stated in the device ifu, the patient obesity, patient post op activity, and length of implantation could have contributed to the event.The extra weight on the implants could cause loosening over time.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 devices are still implanted, a definite root cause cannot be confirmed without evaluating the devices.Device is still implanted.
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