Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device and complaint history records were reviewed, and no relevant manufacturing or similar complaints were identified.Per surgical technique: place the anti-torque key around the screw head.Place the torque wrench through the anti-torque key until it is guided into the blocker.The torque wrench indicates the optimal torque force that must be applied to the implant for final tightening.Line up the two arrows to achieve the final tightening torque of 12nm.Note: do not exceed 12nm during final tightening.Torque wrench was used during the initial surgery and blockers were tightened to 12nm.It is unknown if the length of the rod used was adequate for the construct.X-ray images were not provided.It is unknown if the rod was reduced or was properly seated during initial surgery.Too short rod length can cause the rod to improperly seat in the tulip which may result in the migration of rod post op.The es2 surgical technique recommends the user to ensure that the rod overhangs the last screw head to allow for secure fixation.Due to lack of information, an exact root cause of reported event could not be determined.
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