ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: CENTROIDS WERE PLACED IN THE CENTER OF THE BODIES WITH THE SURGEON'S GUIDANCE. THE MERGE AT ALL LEVELS SHOWED A LARGE SHIFT OF THE VERTEBRAL BODIES IN THE AP VIEW. THE DRR FILE WAS NOTICEABLY A FEW CM TO THE RIGHT OF THE X-RAY ALL LEVELS. SOME TROUBLESHOOTING WAS PERFORMED, BUT THE ISSUE WAS NOT RESOLVED. THE SURGEON DECIDED TO PLACE CAGES WITHOUT NAVIGATION.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: CASE L5-S2AI. THERE WAS BIG SHIFT AT S1, WE CONTINUED TO TAKE NEW PICTURES AND THERE CONTINUED TO BE A LARGE SHIFT AT S1, S2. WE HAD TO DO ANOTHER HARD SHUTDOWN. WE TOOK NEW PICTURES AND THERE IS STILL A BIG SHIFT AT S1, S2.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING THE CASE, A MERGE COULD NOT BE OBTAINED. TRIED TO GET IT AFTER THE CASE BUT IT DID NOT WORK.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: UNSUCCESSFUL MERGE AT T1. MULTIPLE MERGES WERE ATTEMPTED WITH DIFFERENT FLUORO IMAGES AND CENTROID PLACEMENTS. AFTER FAILING T1-T3 MERGE MULTIPLE TIMES, WE TRIED MERGING C7-T2 WHICH WAS ALSO UNSUCCESSFUL.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IN THESE CASES, NO MATTER WHAT, THE MERGE BOUNCED SIMILAR TO E3D.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: T10 -PELVIS WITH S2AI SCREW CASE. ROBOT WAS FINICKY THROUGHOUT CASE, HAD TROUBLES WHEN DROPPING THE DRIVER ARRAY IN. WHEN PUTTING THE DRIVER DOWN THE END EFFECTOR THE SCREW ALIGNMENT WAS OFF, AND THE OFFSET WAS RED. TRIED FIXING THE BALLS AND SWITCHING DRIVER ARRAY. WHEN WE GOT DOWN TO S2AI SCREWS, THE SCREW WAS NOT ALIGNED WITH THE PLAN AND SURGEON HAD TO ABORT THE S2AI SCREWS. SUBMITTED CASE LOGS TODAY.

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 SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND POST OP CT SCAN SHOWS A MEDIAL BREACH OF THE RIGHT L2 SCREW.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE CASE WAS SCHEDULED AS PREOP CT WORKFLOW FOR POSTERIOR PERCUTANEOUS SCREW PLACEMENT WITH THE ROBOT AT L4 AND L5 FOLLOWING AN L4/5 LLIF. THE SCAN UPLOADED WITH NO ISSUES AND WAS CONFIRMED TO BE TO PROTOCOL. THE SURGEON PLANNED SCREWS AT L4 AND L5 WHILE THE PATIENT WAS REPOSITIONED PRONE. DRB AND SM WERE PLACED IN PSIS IN STANDARD ORIENTATION WITH CAMERA AT THE FOOT. THE SM WAS REGISTERED PRIOR TO X-RAY COMING INTO THE FIELD. IMAGES WERE INITIALLY OBTAINED FOR L4 AND L5, BUT THE MERGE WAS UNSUCCESSFUL - WAGGING UP AND DOWN IN THE LATERAL IMAGES AND SLIGHT ROCKING IN THE AP. L3 AND S1 WERE ADDED IN THE WORKFLOW PAGE AND "DUMMY" SCREWS WERE QUICKLY PLANNED AT L3 AND S1. IMAGES WERE OBTAINED FOR L3 AND S1 WITH THE SAME RESULT - UNSUCCESSFUL MERGE WITH WHAT SEEMED LIKE EQUAL MOVEMENT WHEN VERIFYING. NEW SHOTS WERE THEN OBTAINED FOR L4 AND L5 AND ONCE AGAIN WE COULD NOT GET A MERGE, WE WERE CONFIDENT IN ACCEPTING. THE SURGEON BAILED TO TRADITIONAL JAMSHID PLACEMENT, ALREADY FRUSTRATED WITH HIS EXPERIENCES OF THE DAY, ALTHOUGH FLUORO WORKFLOW WAS OFFERED TO HIM.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: HAD A VERY DIFFICULT TIME GETTING A MERGE. THE DRR WAS LESS THAN SUFFICIENT AS FAR AS QUALITY/BEING ABLE TO MERGE WITH OUR FLUORO SHOTS. OUR FLUORO SHOTS I THOUGHT WERE GREAT, BUT ULTIMATELY HAD NO EXPLANATION FOR NOT BEING ABLE TO GET A MERGE. WE WENT BACK ADJUSTED THE WINDOWING ON THE CT. THAT DIDN'T HELP. "DEEP SEARCH" AND "AUTO MERGE" WERE ATTEMPTED SEVERAL TIMES AFTER MOVING THE DRR INTO WHAT I FELT/COULD MAKE OUT TO BE THE MATCHING ANATOMY OF THE FLUORO SHOTS. THERE WAS SOME WEIRD BOX IN THE DRR THAT I COULD NOT EXPLAIN EITHER.

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 NEEDED TO REMOVE AND REPLACE MISPLACED SCREWS THAT WERE PLACED USING THE EXCELSIUS GPS 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 WHILE USING THE EXCELSUS GPS SYSTEM, THE CASE WAS ABORTED DUE TO ROBOTIC ERROR, AND SCREWS WERE THEN PLACED WITHOUT ROBOT.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: SCREW PLACED MEDIAL AT L3.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: C3-T4 OPEN POSTERIOR CERVICO-THORACIC FUSION. 1.1R4 SOFTWARE. PRE-OP CT WORKFLOW. 12" FLUOROSCOPY. CT-SCAN LOADED AND SCREWS PREPLANNED. HE ONLY PLANNED TO USE EGPS TO PUT IN SCREWS AT T2-T4. PRIOR TO THE SURGERY, THE PATIENT HAD A FRACTURE AT C7-T1 CAUSING THE PREVIOUS POSTERIOR SCREWS TO PULL OUT AT T1-T2. DR. (B)(6) PUT THE ANGLED SPINOUS PROCESS CLAMP ON T5 AND DUE TO THE AMOUNT OF SKIN THE ANGLED SPINOUS PROCESS CLAMP WAS POINTING STRAIGHT UP. THUS NOT ALLOWING THE C-ARM INTO TO POSITION FOR REGISTRATION IMAGED. FOLLOWING THAT MISTAKE HE PUT A SHORTER SPINOUS PROCESS CLAMP ON THE SP. SM WAS ON THE SAME CLAMP. THIS ALLOWED THE C-ARM TO MOVE UNDER THE BED WITHOUT HITTING THE MAYFIELD ATTACHMENT HOWEVER, THE LATERAL SHOT WAS DIFFICULT TO VISUALIZE ON THE C-ARM. DR. (B)(6) HAD A DIFFICULT TIME IDENTIFYING EACH LEVEL DUE TO THE MINIMAL CONTRAST OF THE C-ARM. THE SETTING WERE ADJUSTED TO BETTER THE IMAGE ON THE C-ARM BUT THE MERGE WAS UNSUCCESSFUL. THE MERGE LOOKED LIKE IT HAD FOUND THE AN IMAGE ON THE CT THAT WAS IN AN OBLIQUE AP VIEW. FOR THE LATERAL, IT COULD NOT IDENTIFY THE CORRECT LEVEL. WE RESET THE SOFTWARE, FOLLOWED BY COMPLETE REBOOT BUT IT CONTINUED TO FAIL THE MERGE. SCO

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: EXCELCIUS GPS CASE THE FIRST TWO SCREWS WERE MISPLACED OFF PLAN. FLUOR SHOTS WERE TAKEN TO SHOW SCREWS OFF PLAN AND NAVIGATION INACCURATE. REQUESTING EVALUATION OF LOGS SUBMITTED TO IN PORTAL THIS EVENING. EXCELCIUS GPS SERIAL NUMBER (B)(6).

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 WHILE USING THE EXCELSIUS GPS SYSTEM, THE CASE WAS ABORTED DUE TO ROBOTIC ERROR, AND SCREWS WERE THEN PLACED WITHOUT ROBOT.

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 SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: CASE WAS T10-PELVIS. INTRA-OP WORKFLOW. FIRST TWO REGISTRATIONS (L2-S2 AND S2) WENT VERY SMOOTH WITH NO ISSUES. THIRD SPIN WAS T10-L1. SURGEON PLACED SCREWS T10-T12L. WHEN TRYING TO MOVE THE EE CLOSER TO THE ANATOMY THE ARM WOULD NOT ADVANCE WHEN SURGEON BRACELET WAS ENGAGED. THEN WHEN THE SURGEON TRIED TO RESETTLE THE ARM ONTO TRAJECTORY BY USING THE FOOT PEDAL THE ARM DRIFTED INFERIOR AND DID NOT COME BACK ON TRAJECTORY. I CHECKED THE LOADCELL AND ALL VALUES WERE STEADY AT 0. WE REMOVED THE EE AND ADJUSTED THE DRAPE THEN REPLACED THE EE. TRIED TO NAVIGATE TO A TRAJECTORY AND THE ARM DRIFTED THE SAME WAY. I THEN TRIED A MOTION RESET THAT DID NOT WORK. I THEN TRIED A HARD SHUTDOWN AND THAT DID NOT WORK EITHER. THE SURGEON THEN FREEHANDED THE LAST THREE SCREWS. I REMOVED THE ROBOT FROM THE OR AND REHOMED THE ARM AND THAT SEEMED TO FIX IT BUT COULD NOT CONFIRM DUE TO NOT BEING ABLE TO NAVIGATE TO A TRAJECTORY WITH THE EE. PLEASE SEND AN FSE OUT TO CONFIRM THERE ARE NO HARDWARE ISSUES CAUSING THIS ISSUE.

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 NEEDED TO REMOVE AND REPLACE MISPLACED SCREWS THAT WERE PLACED USING THE EXCELSIUS GPS 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 WHILE USING THE EXCELSIUS GPS SYSTEM, THE CASE WAS ABORTED DUE TO ROBOTIC ERROR, AND SCREWS WERE THEN PLACED WITHOUT ROBOT.

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 WHILE USING THE EXCELSUS GPS SYSTEM, THE CASE WAS ABORTED DUE TO ROBOTIC ERROR, AND SCREWS WERE THEN PLACED WITHOUT ROBOT.

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 NEEDED TO REMOVE AND REPLACE MISPLACED SCREWS THAT WERE PLACED USING THE EXCELSIUS GPS SYSTEM.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THIS EVENT OCCURRED WITH THE RIGHT STN LEAD BEING OFF BY MORE THAN 3 MM ON THE FIRST PASS, ESSENTIALLY FALLING INTO THE SAME TRAJECTORY ON THE SECOND PASS, NOT SHIFTING ENOUGH ON THE THIRD PASS, AND FINALLY BEING PLACED IN AN ACCEPTABLE AREA ON THE FOURTH PASS. THE SECOND PASS ONLY THE TARGET WAS ADJUSTED, THE THIRD THE ENTRY WAS ADJUSTED WITH A SLIGHT ADJUSTMENT TO THE TARGET, AND THE FINAL PASS BOTH THE ENTRY AND TARGETS WERE ADJUSTED AGAIN. THERE WAS A LOT OF SPECULATION AS TO WHY THE TRAJECTORY WAS DEVIATING TO SUCH A HIGH DEGREE, THE INITIAL SUSPECT WAS THE MERGE ACCURACY, BUT UPON THE PLACEMENT OF THE LEFT LEAD IT WAS FOUND TO BE LESS THAN 0.9MM OFF AXIS AND VERY CLOSE TO THE PLAN. DR. VARDIMAN'S HYPOTHESIS WAS SOMETHING ANATOMICAL CAUSING THE DEVIATION OR SOMETHING MECHANICAL WITH THE ROBOT. REGARDLESS I BELIEVE THAT IT WARRANTS FURTHER INVESTIGATION I HAVE ALREADY UPLOADED THE CASE.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: WHEN GOING TO VERIFY THE DILATOR (THE ONLY INTERBODY INSTRUMENT THAT THE SURGEON USES FOR TLIFS) WE VERIFIED OFF THE PURPLE T HANDLE ARRAY. THIS DID NOT WORK; IT SHOWED 2 SOLID DOTS AS IT WAS SEEING THE INSTRUMENTS AND VERIFICATION WOULD NOT FAIL OR BE SUCCESSFUL IT DID NOT POPULATE A RED FAILURE OR A GREEN CHECK. I THEN PROCEEDED TO ASK THE TECH TO CHANGE THE SPHERES TO THE BLUE STRAIGHT HANDLE ARRAY TO TRY AND VERIFY DILATOR OFF THAT, THAT FAILED AS WELL. WE THEN TRIED CHANGING ASSIGNED INSTRUMENTS, THIS FAILED TOO. WE THEN WENT BACK TO SCREW INSTRUMENTS AND VERIFIED HIGH SPEED DRILL, THEN WENT BACK TO INTERBODY AND TRIED TO VERIFY DILATOR AGAIN STILL FAILED. AFTER THIS I SUGGESTED WE TRY VERIFYING DILATOR OFF END EFFECTOR. WHEN TRYING TO VERIFY OFF END EFFECTOR SAME THING, IT FAILED. WE THEN RESORTED TO A HARD SHUT DOWN, WHICH IN TURN RESULTED IN US GETTING A RED REHOMING ERROR AND MOTION SELF-CHECK INCOMPLETE. TO POTENTIALLY AVOID HAVING TO REHOME THE ARM, I DID ANOTHER HARD SHUT DOWN, BUT WE STILL GOT THOSE SAME ERROR MESSAGES UPON BOOTING BACK UP. WHEN ATTEMPTING TO REHOME, IT FAILED 4 TIMES AT THIS POINT THE PATIENT WAS IN THE ROOM, AND THEY WERE READY TO POSITION. WE HAD TO

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 MISPLACED SCREWS.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AFTER BOOTING UP THE ROBOT AND LOGGING IN, THE ERROR POPPED UP "MOTION CONTROL SELF-TEST INCOMPLETE". WE DID A HARD SHUT DOWN 8 TIMES ALLOWING AMPLE AMOUNT OF TIME TO SHUT OFF AND LOGGING IN AS WELL. UPON CONTACTING BRITTANY, WE WERE ABLE TO GET ON FACETIME WITH SHANE AND MIKE GILORMA TO GO THROUGH TROUBLESHOOTING STEPS. IT WAS FIXED AFTER GOING THROUGH PROPER STEPS WITH THEM.

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 SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED. THIS WAS A UNILATERAL LEFT SIDED STN INTRAOP CASE THAT RESULTED IN SUB-OPTIMAL ACCURACY FOR THE FIRST LEAD PLACEMENT WITH 2+MM OFF AXIS. WE REPLANNED THE TRAJECTORY AND PLACED A SECOND LEAD WITHOUT REMOVING THE FIRST LEAD AND THEN SCANNED AGAIN WITH THE O ARM. ONCE IT WAS DETERMINED THAT THE SECOND LEAD WAS IN A MORE FAVORABLE LOCATION THE SURGEON OPTED TO REMOVE THE FIRST LEAD AND KEEP THE SECOND LEAD. THE LOCAL IMPLANT TEAM HAS THE CASE LOGS FOR THIS CASE.

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 PATIENT EXPERIENCED ADVERSE EFFECTS FOLLOWING SURGERY WHERE A SCREW WAS MISPLACED 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 REVISION SURGERY WAS DONE TO REPOSITION A MISPLACED L5 RIGHT SCREW.

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 A MISPLACED LEFT SIDE SCREW FROM THE INITIAL OPERATION. THIS EVENT OCCURRED IN (B)(6).

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 WAS MISPLACED AT LS1 AND RIGHT S1, RESULTING IN A DURAL TEAR, WHICH WAS REPAIRED 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 REPRESENTATIVE FROM (B)(6) THAT DRILLING AT L4 TRAJECTORY CAUSED EXCESSIVE BLEEDING TO PATIENT THAT WAS FIXED INTRAOPERATIVELY.

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 WAS MISPLACED AT THE LEFT L5 DUE TO PATIENT MOVEMENT RESULTING IN A DURAL TEAR, WHICH WAS REPAIRED 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 REVISION SURGERY WAS DONE TO REMOVE MISPLACED SCREWS AT L4 CAUSING ADVERSE EFFECTS TO THE PATIENT.

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.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE SYSTEM PLACED SCREWS AT LL AND L4 ACCURATELY, BUT L2 AND L3 WERE WAY OFF. ACCORDING TO THE LOCAL TEAM, THE SURVEILLANCE WAS FINE AND THE MERGE WAS ACCEPTABLE. THE PATIENT IS DOING WELL BUT HAD A SMALL DURAL SCRATCH WHICH WAS REPAIRED INTRA-OPERATIVELY WITH NO SERIOUS LONG-TERM EFFECT TO THE PATIENT.