The reported event could be confirmed according to the manufacturing documentation and the design specifications in the design proposal.The case was a 1-piece lefort i surgery, a bsso, and a genioplasty with a mandibular symphyseal split osteotomy.For this plate the anatomical region was chosen to be the chin area with the 1.7 mm screw system and a profile height of 1.0 mm, which is only approved for pure genioplasty.Due to the additional mandibular symphyseal split of the chin, the application of the plate should have been changed to mandible application, which requires either the 2.0 mm mp or the 2.0/2.3 mm screw system and at least a profile height of 1.2 mm.The manufacturing documentation and the design proposal confirmed that the plate was designed and manufactured with the 1.7 mm screw system and with a profile height of 1.0 mm.The planning of this case including the selection of the screw system was performed by 3d systems per stryker procedure.The design of the plate was finalized by stryker and the incorrectly selected screw system not identified.
|