Description of Event or Problem · 0
THIS CASE WAS A REVISION CASE - L5-S1 BILATERAL SCREWS WERE PREVIOUSLY INSTRUMENTED. L4 WAS INSTRUMENTED USING THE XVS SYSTEM. IN AN OPEN PROCEDURE USING A PERC PIN, THE SURGEON WAS NOTICED TO BUMP INTO PATIENT FIXATION BEFORE INSTRUMENTATION. THE REP NOTIFIED THE SURGEON OF THE BUMP; HOWEVER, THE SURGEON DID NOT WANT TO RE-SPIN. THE SURGEON OPTED TO CONDUCT A THOROUGH ANATOMY CHECK AT MULTIPLE LANDMARKS INSTEAD, TO VERIFY THE REGISTRATION ACCURACY, AND OPTED TO CONTINUE WITH THE NAVIGATION. L4 SCREWS WERE FOUND TO BE POSITIONED INACCURATELY ON AP/LATERAL X-RAY IMAGES. L4 SCREWS WERE REMOVED AND REPLACED ACCURATELY UNDER FLUORO. THE PATIENT IS DOING WELL. THE INVESTIGATION CONCLUDED THAT THE MAIN CAUSE FOR THE DISCREPANCY BETWEEN THE XVS VIRTUAL DISPLAY AND ACTUAL SCREW PLACEMENT, WHICH LED TO INACCURATE SCREW PLACEMENT, IS DUE TO MOVEMENT OF THE FIXATION POINT, WHICH OCCURRED DUE TO THE SURGEON BUMPING INTO IT. THE SURGEON DID NOT FOLLOW THE USER MANUAL INSTRUCTIONS AND EVALUATED THE ACCURACY OF ONLY ANATOMICAL LANDMARKS, PERCUTANEOUSLY. A SCREW THAT IS NOT POSITIONED IN THE PEDICLE AND THAT NEEDED TO BE REMOVED AND REPLACED IS CONSIDERED ACCORDING TO THE ABOVE DEFINITION AS "SERIOUS INJURY". IT IS CLEAR FROM THE INVESTIGATION THAT THE EVENT IS SOLELY THE RESULT OF A USER ERROR OR MISUSE, HOWEVER, THIS ERROR CAUSED PERFORMANCE ISSUES, AS THE SYSTEM DID NOT DISPLAY THE NAVIGATION INFORMATION CORRECTLY. ADDITIONALLY, THE EVENT CAUSED A SERIOUS INJURY. IF A USER MISUSED THE DEVICE, AND THAT RESULTS IN A DEATH OR SERIOUS INJURY, THIS SHOULD BE REPORTED.