CUSTOM MAXILLA IMPLANT

Additional Manufacturer Narrative

INCOMPATIBLE SCREW WAS USED WHICH HAS BROKEN AND CAUSED INCOMPLETE LOADING RESULTING IN LOOSENING.

Description of Event or Problem

THE DEVICE WAS INITIALLY IMPLANTED ABOUT A YEAR AGO AND USED PROPERLY WITHOUT ANY COMPLICATIONS. DURING FOLLOW-UP APPOINTMENTS, A NON-COMPATIBLE/NON-VALIDATED PROSTHETIC SCREW WAS USED WITH THE RESTOR3D IMPLANTS. THE PATIENT IS NOW EXPERIENCING SOME PAIN ON THE LEFT SIDE OF THE MIDFACE. UPON INSPECTION BY A SURGICAL TEAM, THE LEFT PROSTHESIS OF THE MAXILLA WAS VISIBLY LOOSE AND WIGGLES WHEN PRESSED. THE RIGHT SIDE IMPLANT HAS A BROKEN-OFF SCREW IN THE POSTERIOR ABUTMENT, WHICH IS THE NON-COMPATIBLE SCREW.