ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT 2 SCREWS WERE MISPLACED. UPON REMOVAL OF THE SECOND SCREW, THE INTERNAL ILIAC ARTERY WAS PERFORATED CAUSING BLOOD LOSS TO THE PATIENT. THIS WAS RESOLVED AND THE PATIENT IS RECOVERING. THIS EVENT OCCURRED IN BELGIUM.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED BY A REPRESENTATIVE FROM (B)(6) THAT 2 SCREWS WERE MISPLACED. UPON REMOVAL OF THE SECOND SCREW, THE INTERNAL ILIAC ARTERY WAS PERFORATED CAUSING BLOOD LOSS TO THE PATIENT. THIS WAS RESOLVED AND THE PATIENT IS RECOVERING.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE PATIENT HAD A PLANNED SINGLE POSITION LATERAL DECUBITUS SURGERY FOR PEDICLE SCREW FIXATION AND INTERBODY FUSION FROM L4-S1. ROBOTIC GUIDANCE WAS PLANNED FOR PLACEMENT OF PEDICLE SCREWS FROM L4-S1 (6 SCREWS) USING THE GLOBUS EXCELSIUS GPS SYSTEM. TWO SURGEONS TRAINED TO USE THE GLOBUS EXCELSIUS GPS SYSTEM, TWO GLOBUS REPS AND A VASCULAR SURGEON WERE PRESENT DURING THE PROCEDURE. THE ICT (INTRA-OPERATIVE REGISTRATION DEVICE (REFERENCE FRAME)) IS PLACED IN THE ILIAC CREST TO ASSIST WITH IMAGE MERGE. A DYNAMIC REFERENCE BASE (DRB (MOTION CHECKER)) IS ALSO PLACED IN THE ILIAC CREST AND ACTS AS SURVEILLANCE MARKER FOR REAL-TIME INTRAOPERATIVE ACCURACY. THE ROBOTIC SOFTWARE USES AN ALGORITHM TO REGISTER INTRAOPERATIVE FLUOROSCOPY SCAN IMAGES LEVEL BY LEVEL (AP & LATERAL) AND PERFORMS A 2D-3D MERGE WITH A PRE-OPERATIVE CT SCAN. THIS REGISTRATION IS INTENDED TO ENSURE THAT THE RADIOGRAPHIC IMAGES INDICATING THE INTENDED LOCATION OF SURGERY AND THE ACTUAL PATIENT POSITION IN THE O.R. MATCHES, THUS ENABLING THE ROBOT TO GUIDE SCREW PLACEMENT. IN THIS CASE, THE SOFTWARE WAS HAVING DIFFICULTY PERFORMING THE INITIAL IMAGE MERGE AND REGISTRATION. A SOFTWARE RESET WAS ADVISED BY THE REP. FOLLO

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT THE PATIENT EXPERIENCED FOOT DROP POST-OPERATIVELY DUE TO SCREWS THAT WERE NOT PLACED TO PLAN. THE MISPLACED SCREWS WERE REMOVED AND REPLACED.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT A REVISION SURGERY WAS DONE TO REMOVE AND REPLACE 4 SCREWS FROM T12 AND L2 THAT WERE NOT PLACED TO PLAN.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT 4 SCREWS AT L2, L3, L5, AND S1 WERE NOT PLACED ACCORDING TO PLAN. THE SCREWS WERE REMOVED AND REPOSITIONED INTRA-OPERATIVELY.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS ANOTHER PREOP CASE IN (B)(6), SCREWS REVISION S1L AND S1R. THE FF WAS ATTACHED IN THE CENTER WITHOUT THE GAP BETWEEN THE DETECTOR AND FF. I HAVE CHECKED THE MARKER'S POSTS ON THE FF AND THE GPS INSTRUMENTS, AND NO BENT POSTS WERE SEEN. DRB AND SM WERE PLACED AS USUAL ON THE RIGHT AND LEFT SIDE. DESPITE A GOOD REGISTRATION SCORE(8,9), WE GOT SHIFT IN THE AP SHOTS. NOTHING WAS MOVED DURING THE REGISTRATION, THE C-ARM WAS BRAKED, AND THE PATIENT AND TABLE WERE NOT MOVED. DURING THE X-RAYS THE MOVEMENT BAR WAS MOVING FROM GREEN TO YELLOW. WE TOOK A SECOND ATTEMPT, AND TRIED TO GET THE SHOTS, HAVING THE GREEN BAR. AFTER NEW LATERAL SHOOTS THE MERGE WAS GOOD, AND WE COULD PROCEED TO THE NAVIGATION. 3. AT THIS POINT THE SM TURNED TO RED AND THEN TO YELLOW, DESPITE NOTHING BEING MOVED OR CHANGED. THE SURGEON CHECKED THE NAVIGATION ACCURACY AT THE SKIN LEVEL AND DECIDED TO DO THE SKIN INCISION, WITHOUT TO RESET THE SM. HE CHECKED THE ACCURACY INSIDE THE WOUND, TAPING THE SPINAL PROCESS AND SCREWS HEADS. THE ACCURACY WAS GOOD, AND SM WAS DEACTIVATED AND ACTIVATED AGAIN AND WAS GREEN. DURING THE CASE, SURGEON CHECKED MULTIPLE TIMES THE NAVIGATION ACCURACY AND IT WAS GOOD. THE CONTROL X

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT THE LEFT L4 SCREW WAS NOT PLACED ACCORDING TO THE SURGICAL PLAN. THE SCREW WAS REMOVED AND REPOSITIONED INTRA-OPERATIVELY.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT A SCREW PLACED AT L5 WAS NOT PLACED ACCORDING TO THE SURGICAL PLAN. THE MISPLACED SCREW WAS REMOVED.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT THE RIGHT L4 SCREW WAS NOT PLACED ACCORDING TO PLAN. THE SCREW WAS REMOVED AND REPLACED IN THE PROPER POSITION.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT FIVE PEDLCLE SCREWS WERE NOT PLACED ACCORDING TO THE SCREW PLAN AT THE LEFT T8-T12 LEVELS. ALL PEAICIE SCREWS FROM T8-T12 AND THE RIGHT SIDE SCREW AT T12 WERE REMOVED AND REPLACED USING TRADITIONAL MIS TECHNIQUE.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT TWO PEDICLE SCREWS WERE NOT PLACED ACCORDING TO THE SCREW PLAN AT LEFT L3 AND RIGHT L4. INTRA-OPERATIVE IMAGING SHOWED THAT THE L3 SCREW WAS PLACED SUPERIOR IN THE DISC SPACE, AND THE L4 SCREW WAS LATERAL OF THE VERTEBRAL BODY. THE SCREWS WERE REMOVED AND PLACED USING NAVIGATED INSTRUMENTS BUT WITHOUT USE OF THE ROBOTIC ARM.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT TWO PEDICLE SCREWS WERE NOT PLACED ACCORDING TO THE SCREW PLAN AT THE LS LEVEL. INTRA-OPERATIVE IMAGING SHOWED THAT THE SCREWS WERE PLACED THROUGH THE SUPERIOR ENDPLATES AND BORDERS OF THE PEDICLES. THE SCREWS WERE REMOVED AND PLACED WITHOUT USE OF THE SYSTEM.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT FOUR PEDICLE SCREWS WERE NOT PLACED ACCORDING TO THE SCREW PLAN USING THE, EXCELSIUS GPS SYSTEM, AT THE L3-4 LEVEL. INTRA-OPERATIVE IMAGING SHOWED THAT THE TWO LEFT SCREWS WERE PLACED MEDIALLY AND THE TWO RIGHT SCREWS WERE PLACED LATERALLY. THE SCREWS WERE REMOVED AND PLACED WITHOUT USE OF THE SYSTEM.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT FOUR PEDIC/E SCREWS WERE NOT PLACED ACCORDING TO THE SCREW PLAN. INTRA-OPERATIVE IMAGING SHOWED THE SCREWS WERE PLACED MEDIALLY AND WERE OFF BY TWO VERTEBRAL LEVELS. THE SCREWS WERE REMOVED AND NEW ANTERIOR, POSTERIOR, AND LATERAL C­ ARM IMAGES WERE REGISTERED AND MERGED. USING THE EXCELSIUS GPS, THE SCREWS WERE CORRECTLY PLACED AT LS AND S1 ACCORDING TO THE INITIAL PLAN.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THE LEFT LS SCREW WAS PLACED LOW TO PLAN. THE SCREW WAS REPOSITIONED INTRA-OPERATIVELY TO A NEW TRAJECTORY USING FLUOROSCOPIC IMAGING. IMMEDIATELY POST-OPERATIVE THE PATIENT HAD LIMITED MOVEMENT TO THE LOWER LEG AND FOOT. 28 DAYS LATER, THE SURGEON REPORTED THAT THE PATIENT HAD STARTED TO RECOVER MOVEMENT AND BELIEVED THIS IMPROVEMENT WOULD CONTINUE.