A comprehensive investigation was immediately initiated on receipt of the complaint.A review of all applicable material, inspection, manufacturing, and distribution records according to the description of the product(s) used was conducted.All records revealed that all product(s) lots were manufactured within specifications and distributed in accordance with all operating procedures.The patient was treated for congenital scoliosis, and the complexity of the deformity coupled with anatomical constraints prohibited screws from being inserted at every level of the construct.The limited screw density and complex deformity resulted in an uneven distribution of stress, and the axial slip was isolated to the screw carrying the most significant load.The wear pattern on the bottom of the screw indicated that the screw was properly seated across the rod.Additional markings on one of the set screws indicate that it was subjected to axial slip.The hexalobe and threads of the screw remain intact.
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