ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: SYSTEM WILL NOT BOOT ALL THE WAY UP. RED LIGHT ON SCREEN. SUBTLE BEEPING NOISE COMING FROM THE CABINET.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE DOCTOR'S PATIENT HAD A GRADE 4 SPONDY AT L5-S1 WITH A PLAN TO PUT PEDICLE SCREWS AT L5-S1 AND THEN A SI-BONE DOWEL POSTERIORLY THROUGH S1 GOING ANTERIORLY TO L5 BODY. HE PLANNED A S2A1 SCREW FOR THE SI BONE, WE PLANNED A L4 MCS SCREW OVER HIS S2AI PLAN BECAUSE HE WANTED TO SEE A PROPER CAD OF MCS DRILL. HIS PLAN WAS TO USE THE ROBOT FOR TRAJECTORY, MCS DRILL, AND PLACING A K-WIRE. WENT TO MERGE, PLACED CENTROIDS, IMMEDIATELY NOTICED A SHIFT. HAD MORE SHOTS TAKEN LATERALLY AND AP, STILL HAD LOW MERGE SCORES AND SHIFT. SURGEON AT THIS POINT DECIDED TO BAIL ON ROBOT, AFTER TAKING ROBOT OUT I PLANNED SCREWS WHERE THEY SHOULD BE GOING AND GOT A SUCCESSFUL MERGE.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: WHILE A FIELD SERVICE ENGINEER WAS ON SITE FOR ANOTHER COMPLAINT, THE SURGEON MENTIONED TO ENGINEER THAT HE HAD MISPLACED SCREWS DURING HIS THIRD CASE OF THE DAY.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative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

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: WHEN ROBOT WAS PLUGGED IN, IT WOULD POWER UP BUT THEN START BEEPING AND BATTERY STATUS BAR WAS STUCK ON 2 BARS AND NOT CYCLING LIKE NORMAL. TURNED OFF ROBOT AND POWERED UP AGAIN AND BEEPING STOPPED BUT STILL WAS NOT WORKING PROPERLY. SHUT DOWN ONE LAST TIME AND POWERED BACK UP AND STARTED BEEPING AGAIN.

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 DURING A PROCEDURE USING THE EXCELSIUS CRANIAL APPLICATION, SEVERAL BIOPSY SAMPLES WERE TAKEN AND CAUSED BLEEDING THAT WAS FIXED INTRAOPERATIVELY. THIS EVENT OCCURRED IN POLAND.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: CALLED SERVICE WHEN THE ROBOT BATTERY WOULD NOT CHARGE. WAS TOLD THE ROBOT WOULD STILL GET POWER WHILE PLUGGED IN, IT WAS WORKING FOR AROUND AN HOUR THEN POWERED DOWN BEFORE REGISTRATION AND WOULD NOT START. SURGERY ABORTED.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DOCTOR WAS PERFORMING A SINGLE POSITION LATERAL FUSION AND WE HAD ISSUES WITH THE MERGE. THE LEVELS IN QUESTION WERE L3 AND L4. THERE WAS SIGNIFICANT SHIFT IN THE A/P AND LATERAL IMAGES WHEN COMPARED TO THE CT SCAN. THIS WAS ATTEMPTED TO BE FIXED BY SEGMENTING THE LEVELS SO THAT EACH LEVEL WAS ON A SEPARATE X-RAY. ALSO, WE ADDED L2 AND L5 TO HELP CORRECT THE SHIFT BUT IT DID NOT WORK. CSR WAS AT THE CASE AND HAS THE LOGS. WE FOLLOWED HIS RECOMMENDATIONS FOR TRYING TO FIX THE SHIFT. WE WERE UNABLE TO FIX THE SHIFT AND THE ROBOT PORTION OF THE CASE WAS ABORTED.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: HAD TO SHUT OFF 7 TIMES THROUGH OUT CASE TO EITHER GET IT TO SHOW US INSTRUMENTS THAT HAD ALREADY BEEN CHECKED IN BUT WAS SAYING THEY HAD NOT.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REHOMING ARM WOULDN'T WORK.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ROBOT NEVER CONFIRMED WE WERE IN TARGET OR WOULDN'T SEND TO ANY TRAJECTORIES.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE SYSTEM WAS INITIALLY TURNED ON, ALL CHECKS PERFORMED, INSTRUMENTS VERIFIED ETC. THE SYSTEM WAS THEN SHUT DOWN FOR STAGE 1 OF THE PROCEDURE (AS INFORMED PREVIOUSLY BY INR TEAM TO NOT LEAVE ROBOT SWITCHED ON FOR A LONG TIME BEFORE THE CASE STARTS). WHEN TURNING THE SYSTEM BACK ON FOR COMMENCEMENT OF STAGE 2 THE SCREEN DISPLAYED "REBOOT AND SELECT PROPER BOOT DEVICE OR INSERT BOOT MEDIA IN SELECTED BOOT DEVICE AND PRESS A KEY". LOCAL INR SUPPORT INFORMED US TO SWITCH OFF BATTERY AND RESTART SYSTEM USING AC POWER ONLY OR TO RESTART SYSTEM WHILE HOLD "ESC". NEITHER OF THESE RESOLVED THIS ISSUE AND THE CASE WAS ABANDONED. AFTER THE CASE WE TROUBLESHOOTED WITH INTERNATIONAL INR SUPPORT AND WERE ABLE TO "DISABLE LEGACY BOOT MODE".

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING LAST SCREW PLACEMENT (L5R) THE HIGH SPEED DRILL, PILOT DRILL AND THE TAP WERE NAVIGATED ACCURATELY, BUT SCREW WAS NOT. THE SCREW WAS PUT SLIGHTLY IN FORAMEN, IT WAS FOUND IN THE X-RAY VERIFICATION SHOT. SCREW WAS IMMEDIATELY REMOVED AND RE-PLANNED AND AGAIN - HIGH SPEED DRILL, PILOT DRILL AND TAP WERE NAVIGATED ACCURATELY, BUT DURING SCREW PLACEMENT THE DOCTOR SAW AND FELT THAT THE SCREW JUMPED INTO OLD CANAL. ONCE MORE SCREW WAS IMMEDIATELY REMOVED AND RE-PLANNED AND AGAIN HIGH SPEED DRILL, PILOT DRILL AND TAP WERE NAVIGATED ACCURATELY, BUT SCREW WAS PUT WITHOUT ROBOT/NAVIGATION WITH STANDARD SCREWDRIVER AND UNDER X-RAY CONTROL. AFTER DISCUSSION WITH THE REP HE COULDN'T CONFIRM THAT THE OFFSET TURNED TO RED WHEN SCREWDRIVER WAS IN EE.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE ROBOT SEEMED TO BE MORE SENSITIVE THEN USUAL AND A SCREW ACTUALLY SEEMED TO MISS LATERALLY. TO HELP WITH EXAMINING WHAT WENT WRONG, THE DIFFICULTIES WE HAD PERSISTED ON THE PATIENTS RIGHT SIDE. THE PA SEEMED TO THINK THE TRAJECTORY LOOKED PERFECT UNTIL IT CAME TIME FOR THE DRIVER ARRAY TO PASS DOWN THE END EFFECTOR, THEN SHOWING A SUDDEN CHANGE IN TRAJECTORY. I AM UNSURE IF AN ISSUE COULD BE RELATED TO TECHNIQUE OR NOT. WE HAVE SINCE USED THE ROBOT THIS WEEK AND DID NOT SEEM TO HAVE ISSUES.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THIS EVENT OCCURRED IN AN INTRA-OP T10-PELVIS REVISION CASE. EXISTING HARDWARE WAS PRESENT FROM L3-S1. AFTER ALL STEPS OF THE INTRA-OP WORKFLOW HAD BEEN COMPLETED, A THOROUGH AND DETAILED ANATOMY CHECK WAS DONE. THE SURGEON AND HIS FELLOW ADJUSTED ALL SCREWS THAT HAD BEEN PRELIMINARILY PLANED. AFTER THE SURGEONS MODIFIED, REVIEWED, AND APPROVED ALL SCREWS; THE ROBOT WAS PUSHED INTO THE CORRECT POSITION. SCREWS WERE PLACED T10-L2 ON THE LEFT PRIOR TO PLACING SCREWS T10-L2 ON THE RIGHT (SURGEON PREFERENCE). S2AI SCREWS WERE PLACED LAST. ACCURACY CHECKS WERE CONDUCTED THROUGHOUT THE SCREW PLACEMENT PROCESS A SPIN WAS CONDUCTED AFTER ALL SCREWS WERE PLACED. THE LEFT T10 SCREW APPEARED TO BREACH THE MEDIAL WALL OF THE PEDICLE AND THE SCREW APPEARED SLIGHTLY MEDIAL TO THE PLAN. THE EXTENT OF THE BREACH COULD NOT BE DETERMINED DUE TO THE SCAN QUALITY (VERY POOR DUE TO THE PATIENT SIZE AND METAL SCATTER). THE SURGEON CAREFULLY REVIEWED THE SCREW AND NEURO MONITORING DATA BEFORE DECIDING TO LEAVE IT IN PLACE. THE LEFT T10 PEDICLE WAS SMALL, AND THE SURGEON SELECTED A SCREW DIAMETER THAT WAS CLINICALLY APPROPRIATE AND HIM EFFECTIVE FIXATION. THE SURGEON FELT IT WAS POSSIBLE THAT THE 4.5 HIGH

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING L3-L4 SPL CASE, C-ARM IMAGES WERE MIRRORED AFTER THE MERGE. BEFORE THE MERGE, EVERYTHING WENT NORMALLY: IMAGES WERE TRANSFERRED NORMALLY, CENTROIDS WERE PLACED BUT AFTER MERGING C-ARM SHOTS WERE REVERSED. RE-IMAGING THE PATIENT, RESETTING SOFTWARE, RESTARTING C-ARM, RESTARTING EGPS, CREATING NEW CASE DID NOT SOLVE THE PROBLEM. ALSO DURING PANNING PHASE, THE ANTERIOR PART OF THE CAGE NEEDED TO BE PLANNED POSTERIORLY TO GET LEFT SIDE ACCESS. PROCEDURE WAS PERFORMED THE OLD FASHION WAY.

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 DURING A PROCEDURE USING THE EXCELSIUS GPS SYSTEM, A PEDICLE PROBE WAS PLACED AND A MEDIAL BREACH WITH CEREBROSPINAL FLUID LEAK WAS OBSERVED AND 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 PATIENT EXPERIENCED ADVERSE EFFECTS FOLLOWING SURGERY WHERE A SCREW USING THE EXCELSIUS GPS SYSTEM WAS MISPLACED INTRA-OPERATIVELY CAUSING A LEFT MEDIAL BREACH.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING NAVIGATION, WHILE MOVING TO TRAJECTORY FOR OUR L5 R AND S1 R SCREWS THE AXIAL SLICE WAS UNRECOGNIZABLE (COULD NOT MAKE OUT ANY PEDICLE, VERTEBRAL BODY, S.P). WE CHECK OUR LEFT SIDED SCREWS TRAJECTORY, AND EVERYTHING LOOKED PERFECT. I WENT BACK TO THE PLANNING PAGE TO CHECK OUR RIGHT SIDED SCREWS AXIAL IMAGES AND AGAIN, EVERYTHING LOOKED PERFECT. THOUGH, WHILE BRINGING INSTRUMENTS IN THE EE ALL INSTRUMENT TRACKED CORRECTLY DOWN PLANNED SCREW TRAJECTORY EVEN THOUGH IT DID NOT VISIBLY LOOK LIKE A CORRECT AXIAL SLICE (ANATOMY UNRECOGNIZABLE). AFTER A FEW SOFTWARE RESETS AND A HARD SHUT DOWN, AND SWITCHING EES I INFORMED DR. GENTRY IT WAS JUST THE SLICE OF THE SCAN WE WERE IN, AND I BELIEVED EVERYTHING WAS SAFE. WHEN ADDING LAYERS TO OUR AXIAL CUT THE IMAGE WAS IMPROVING (COULD MAKE OUT DISTINCT ANATOMY) BUT DOC STILL DID NOT TRUST IT. ADJUSTING THE PLAN HAD LITTLE TO NO EFFECT AS WELL. HE WOULD NOT MAKE AN INCISION TO CHECK TRAJECTORY OF INSTRUMENTS UNDER FLOURO AND BAILED ON THE ROBOT.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: CHECKED THE SYSTEM AFTER REPLACING THE FUSES AND FOUND THAT THE POWER IS BACK ON THE SYSTEM WITH POWER AND BATTERY LED INDICATOR ON THE CONTROL PANEL. SYSTEM'S FANS WERE ALSO RUNNING BUT THERE WAS NO DISPLAY ON THE MONITOR. LED ON THE MONITOR IS RED. I.E. NO VIDEO SIGNALS FROM COMPUTER. 2. CONNECTED AN EXTERNAL HDMI CABLE FROM PC TO MONITOR DIRECTLY BUT STILL NO VIDEO SIGNAL ON MONITOR. 3. CONNECTED EXTERNAL MONITOR ON THE PC DIRECTLY AND NO DISPLAY ON THE EXTERNAL MONITOR TOO. 4. CHECKED THE VOLTAGE ON PC POWER SUPPLY AND IT WAS 54 VOLT DC. 5. PC FAN WAS ALSO RUNNING. 6. IT HAS BEEN OBSERVED THAT THE PC IS NOT BOOTING UP SO THERE IS NO DISPLAY ON THE MONITOR. KINDLY SUGGEST FURTHER.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: FAILED MERGE OF L4 DURING AN L4-L5 SINGLE POSITION LATERAL. PATIENT WAS POSITIONED LEFT SIDE UP AND THE BED WAS BROKEN SLIGHTLY PRIOR TO DRAPING THE PATIENT. IMAGES WERE ACQUIRED FOR THE MERGE. WE WERE ABLE TO GET A GOOD/APPROVABLE MERGE FOR L5 ON THE FIRST ATTEMPT. DESPITE MULTIPLE ATTEMPTS AND EXTENSIVE TROUBLESHOOTING, WE WERE NOT ABLE TO GET A GOOD/APPROVABLE MERGE FOR L4. THE AP VIEW CONSISTENTLY HAD MORE SHIFT THEN IN THE LATERAL AT L4.

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. THIS EVENT OCCURED IN BELGIUM.

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.