Description of Event or Problem · 0
A CASE WAS PERFORMED ON L5-S1 WITH THE XVS SYSTEM. 4 PERCUTANEOUS SCREWS WERE PLACED INACCURATELY. PERC PIN 125MM WAS PLACED IN THE PATIENT'S LEFT PSIS. XLINK STICKER PLACED MIDLINE WITH AN ARROW FACING CAUDALLY. NO ISSUE WITH SCAN TRANSFER OR IMAGE CAPTURE OF BEADS. PERC PIN ADAPTOR CONFIRMED TO BE TIGHTENED FULLY BEFORE CAPTURING XLINK. THE LANDMARK CHECK WAS CONFIRMED. THE SURGEON BEGAN INSTRUMENTING ON THE PATIENT'S LEFT SIDE. INSTRUMENT WORKFLOW INCLUDED DRILLING PILOT HOLE WITH BURR FOLLOWED BY SCREW PLACEMENT WITH NUVASIVE ALL-IN-ONE DRIVER. THE SURGEON PLACED FOUR (4) 6.5MMX45MM SCREWS TOTAL. THE SURGEON WAS HAPPY WITH NAVIGATED TRAJECTORIES. UPON TAKING CONFIRMATION IMAGES WITH C-ARM, THE SURGEON POINTED OUT ALL 4 PEDICLE SCREWS LOOKED LOW (INACCURATE) IN THE FLUORO SHOTS COMPARED TO THE NAVIGATION. THE SURGEON CHECKED THE PERC PIN ADAPTOR PRIOR TO AND AFTER THE O-ARM SPIN AND CONFIRMED ITS RIGIDITY. THE SURGEON WAS NOT HAPPY WITH SCREW PLACEMENT AND REMOVED ALL FOUR SCREWS PLACED WITH XVISION AND REVISED ALL FOUR PEDICLE SCREWS WITHOUT NAVIGATION. THE INVESTIGATION CONCLUDED THAT THE MOST PROBABLE CAUSE FOR SCREW INACCURACY WAS PERC PIN ADAPTOR MOVEMENT AT THE BEGINNING OF THE PROCEDURE FROM AN UNKNOWN CAUSE. IN THIS CASE, THE PERC PIN ADAPTOR MOVEMENT WAS NOT DETECTED BECAUSE THE LANDMARK CHECK WAS DONE ON THE SKIN AND ON THE PIN ITSELF, AND NOT ON THE BONE ANATOMY AS RECOMMENDED TO THE USER, THEREFORE IT IS CONSIDERED AS A USER ERROR FAILURE. IN ADDITION, WHILE INVESTIGATING THE PERC PIN ADAPTER USED IN THIS CASE, IT WAS FOUND THAT THE ADAPTOR MAY HAVE NOT BEEN FIXATED WELL TO THE PERC PIN DUE TO A MALFUNCTION PROBABLY ORIGINATING FROM THE MANUFACTURING PROCESS OF THIS COMPONENT.