This report is being resubmitted for an incident that occurred earlier.Evaluation of the returned device found one set screw is in the locked position.This set screw is on an end level and corresponds to the position of the screw which was backed out of the plate.There is damage to the set screw which relates to the position of the screw head.This damage can caused by angulating the screw farther than the allowable range during implantation, or the screw backing out of the plate and deforming the set screw in the process.Based upon the x-rays provided, the screws do not appear to have a steep angle but since settling may have occurred since the primary surgery, it is possible the screws were implanted on a higher angle.While the exact cause of the reported issue cannot be determined, it's possible that improper screw angle may have contributed.
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