ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: EGPS BATTERY DOES NOT HOLD ANYMORE. PLEASE SEND A FSR IMMEDIATELY TO REPLACE AND DO A SERVICE ON OUR MACHINE AT WESTCHESTER MEDICAL CENTER.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: 11-L3 PSF, BURST FRACTURE AT L1WITH DR. (B)(6) AT (B)(6). ALL SCREWS WERE PLACED IN A SERPENTINE ORDER WITHOUT ANY DIFFICULTY UP UNTIL RL3. 4.5 HS BURR WAS USED THEN DRILL WAS USED IN SCLEROTIC BONE. RESIDENT STRUGGLED GETTING THE DRILL THROUGH THE PEDICLE. DURING THIS TIME THE DRILL HAD SKIVED MEDIALLY. DR. (B)(6) AND RESIDENT TRIED RE-DRILLING AND TAPPING TO GET TO THE CORRECT TRAJECTORY. NAVIGATION LOOKED INTACT AT ALL TIMES. UPON GETTING A FINAL SPIN IT WAS NOTED THAT RL3 HAD JUST BREACHED MEDIALLY. DR. (B)(6) HAD DECIDED HE WOULD FREEHAND RL3 TO BRING IT LATERALLY. ANOTHER SPIN WAS PERFORMED AND THE SCREW WAS STILL MEDIAL. SCREW WAS TAKEN OUT AND PUT IN UNDER XRAY.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE SURGEON MISSED SCREWS IN LOWER HALF OF THE CONSTRUCT AS IT APPEARED TO SHIFT. WE PERFORMED AN O-ARM SPIN AFTER SEEING SCREWS APPEARED OFF TRAJECTORY AND IT REVEALED THAT THERE WAS A SCREW THAT MISSED LATERALLY AND ONE MEDIALLY AT L1 AND L2. THEN TRIED TO REPOSITION SCREWS AFTER SPIN (2ND FILE) AND THEY DIDN'T WANT TO GOIN THE NEW TRAJECTORY SO IT WAS ABORTED.

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 AN INTERBODY SPACER WAS MISPLACED INTRA-OPERATIVELY WHILE USING THE EXCELSIUS GPS SYSTEM TO PREPARE THE DISC SPACE RESULTING IN A DURAL TEAR.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: WE DID AN L3-5 PSF WITH ROBOT USING MCS SCREWS. BOTH OF THE SCREWS AT L3 SHIFTED TO THE LEFT. THE RIGHT SCREW WENT MEDIAL AND THE LEFT SCREW WAS LATERAL. IT WAS IDENTIFIED BY NEUROMONITORING UPON STIMULATION AND THEN CONFIRMED WITH ANOTHER INFRA OP SPIN. WE BACKED THE SCREWS OUT AND REPLACED THEM WITH ROBOTIC GUIDANCE USING THE SECOND O-ARM SPIN. ALL OTHER SCREWS WERE FINE.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: BEFORE A CASE, WE WERE TRYING TO UPLOAD THE PATIENT SCAN AND THE ROBOT WAS NOT RECOGNIZING THE CD DRIVE. WE TRIED BOTH USB PORTS, DID A SOFTWARE RESET AND THEN A HARD RESET. WHEN TURNING BACK ON WE GOT A BLACK PAGE SAYING, "REBOOT AND SELECT PROPER BOOT DEVICE OR INSERT BOOT MEDIA IN SELECTED BOOT DEVICE AND PRESS A KEY_".

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE ARM AND VERIFICATION PROBE WERE AGAIN USED TO CONFIRM THE ENTRY POINTS. A STRYKER PERFORATOR WAS USED TO CREATE A SINGLE BURR HOLE ON THE PATIENTS RIGHT. A STIM-LOCK WAS OPENED AND USED TO TEMPLATE AN AREA THAT THE SURGEON BURRED DOWN WITH A ACORN BIT TO RECESS THE STIM-LOCK. THE ARM WAS SENT AGAIN TO CONFIRM ACCURACY AT THE CENTER OF THE BURR HOLE. THE IGEE TOP TO TARGET WAS SET TO 183MM AND A 216.5MM ALPHA OMEGA CANNULA WAS PLACED TO APPROXIMATELY 10MM ABOVE TARGET. E3D WAS MOVED BACK INTO PLACE AND A SPIN WAS PERFORMED SHOWING A DEVIATION MEDIALLY APPROXIMATELY 1.25MM. THE SURGEON CHECKED ON THE BRAINLAB SERVER AND SAID THAT THEY SHOWED APPROXIMATELY 2.5MM OF DEVIATION. THE AO HEAD STAGE WAS REMOVED AND THE ARM RESETTLED, THIS TIME TO 168MM IGEE TOP TO TARGET. A 201.5MM AO CANNULA WAS PLACED AND E3D WAS MOVED BACK INTO TO POSITION AND ANOTHER SCAN WAS PERFORMED. IT WAS LOADED ONTO THE ROBOT AND AN EVALUATION SHOWED ALMOST IDENTICAL DEVIATION, SUGGESTING THE CANNULA FELL INTO THE PREVIOUS TRACK. THE SURGEON BELIEVED THE TRAJECTORY SET BY THE ROBOT WAS CORRECT, BUT THE CANNULA DEVIATED DUE TO POSSIBLE ANATOMY. HE ADJUSTED THE ALPHA OMEGA XY BASE TO CORRECT FOR THE DEVIATION AN

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THIS WAS AN EGPS CRANIAL BIOPSY CASE USING CT-FLUORO REGISTRATION WORKFLOW. DURING PATIENT REGISTRATION, USER COULD NOT ACHIEVE AN ACCURATE MERGE OF PRE-OP CT TO INTRA-OPERATIVE FLUORO SHOTS. REQUESTING SOFTWARE INVESTIGATION OF THE MERGE ATTEMPTS.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: L4R WAS PLANNED ON A POTENTIAL SKIVE ZONE DUE TO THE PATIENT'S ANATOMY AND THE SURGEON'S TRAJECTORY PREFERENCE (STRAIGHT UP AND DOWN, MID-LINE ALONG THE FACET JOINT, WHICH WAS HYPERTROPHIC IN THIS CASE). THE SURGEON'S TECHNIQUE IS EXTREMELY FAST WITH THE HS BURR, RD, AND DRIVER ALL ON POWER. HE PLACED THE SCREWS AT L4R VERY QUICKLY AND MOVED ONTO THE NEXT. THE EGPS BASE HAD TO BE BACKED AWAY FROM THE PATIENT DUE TO THE ARM CONTRACTING THE PATIENT ANATOMY AND THE LAST TWO SCREWS WERE PLACED WITHOUT ISSUE. THE C-ARM WAS BROUGHT IN FOR CONFIRMATION SHOTS AND IT WAS FOUND THAT THE L4R SCREW HAD SKIVVED OFF OF THE HYPERTROPHIC FACET AND HAD ANGLED CRANIAL, MISSING THE PEDICLE. HOWEVER, THE SOFTWARE HAD GIVEN A CHECKMARK FOR THIS TRAJECTORY.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: WHEN NAVIGATING DRIVER, NAVIGATION LOOKED ACCURATE, IF ANYTHING SLIGHTLY OFF TRAJECTORY LATERALLY IN OUR AXIAL SLICE (STILL SAFELY IN BONE), BUT ACCURATE TO PLAN IN SAGITTAL. SINCE SCREW WAS OFFSET LATERALLY, THERE WAS DIFFICULTY INSERTING THE ARRAY ALL THE WAY THROUGH EE AND DOCTOR FELT TACTILE FEEDBACK WAS OFF, DRIVER WAS REMOVED AND C-ARM WAS BROUGHT IN FOR IMAGES. THE SCREW WAS INSERTED ON PLAN BUT AND HALFWAY THROUGH THE PEDICLE BROKE OUT SUPERIOR AND WAS IN DISC SPACE (FLUORO SHOT INCLUDED). THIS DID NOT SHOW ON NAVIGATION. MINOR ADJUSTMENTS WERE MADE TO THE PLAN. HIGH SPEED BURR WAS INSERTED THROUGH EE INTO PRIOR HOLE AND FLUORO SHOW ACCURATE TO PLAN, SAME WITH 3.5MM PILOT DRILL. A NEW SCREW WAS INSERTED TO PLAN AND NO ADVERSE EFFECTS TO THE PATIENT WERE PRESENTED THROUGH NEUROSTIMULATION.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: L3-S2AI FUSION - REVISION OF PREVIOUS FUSION. EGPS 1.4 SOFTWARE. INSTRUMENTS VERIFIED, ARM AND MONITOR DRAPED PRIOR TO CASE START. SCREWS PLANNED BY DR. (B)(6) BEFORE PATIENT ENTERED THE ROOM. EGPS POSITIONED ON THE SAME SIDE AS OR DOOR AND OPPOSITE DR. (B)(6). EGPS AT THE HEAD OF THE BED AND OPPOSITE SAM, THE SCRUB TECH, AND IMPLANT/INSTRUMENT TRAYS. C-ARM #8 USED FOR THE CASE. IT IS THE ONLY FUNCTIONING C-ARM AT THE ACCOUNT. THE DRB WAS PLACED IN THE RIGHT PSIS VIA THE LONG QUATTRO SPIKE AND SM PLACED IN THE OPPOSITE PSIS. DR. (B)(6) PLACED BOTH WITHIN HIS OPEN INCISION BY DISSECTING THE SKIN FROM THE FASCIA.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: 1-ROBOT WILL NOT HOLD A CHARGE OR STAY CHARGED, WHEN UNPLUGGED FROM THE WALL IT IMMEDIATELY DIES, POWERS DOWN.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: UPON REVIEW OF THE POST-OP O-ARM 2 SPIN, IT WAS OBSERVED THAT THE L4L SCREW MISSED PLAN LATERALLY. THE L4L SCREW WAS THEN REPLANNED, REINSTRUMENTED, AND A POST-OP SPIN SHOWED IT ACCURATELY PLACED TO PLAN. DR.(B)(6) IS ASKING FOR GUIDANCE AS TO THE LIKELY CAUSE OF THE LATERAL MISPLACED SCREW.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE NAVIGATION WAS OFF DURING SURGERY AND SOME SCREWS WERE MISPLACED.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING AN INTRA-OP L5-S2A1 REVISION CASE, AFTER AN O-ARM SPIN WAS PERFORMED AND WHEN ATTEMPTING TO TRANSFER THE SCAN TO THE ROBOT, THE SYSTEM WAS STUCK ON THE UPLOADING SCREEN AND WOULD NOT PROCEED OR RESPOND TO ANY INPUTS. THE SYSTEM WAS THEN SHUTDOWN, THE CASE RE-OPENED AND THE LIFESAVER BUTTON WAS PRESSED, AND A NEW SNAPSHOT WAS TAKEN AS NOTHING HAD MOVED ON THE TABLE. THE INITIAL SCAN WAS DELETED OFF THE ROBOT AND THE SAME SCAN FROM THE O-ARM WAS UPLOADED UNDER A DIFFERENT FILE NAME. AFTER THE NEW SCAN WAS TRANSFERRED TO THE ROBOT VIA USB, THE SAME ISSUE PERSISTED WHERE IT WOULD GET STUCK ON THE UPLOADING SCREEN. AT THIS POINT, THE SURGEON DECIDED TO ABORT ROBOTIC NAVIGATION AND PROCEED WITH THE CASE USING FLUORO.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THERE WAS AN INCIDENT DURING A CASE AT CONWAY MEDICAL CENTER YESTERDAY WHERE EGPS PLACED TWO SCREWS AT L3 USING E3D AND INTRAOPERATIVE WORKFLOW. BOTH SCREWS GOT A CHECK MARK ON THE ROBOT WHEN THEY WERE PLACED, BUT THE LEFT SCREW WAS SIGNIFICANTLY LATERAL TO THE PLAN AND THE RIGHT SCREW WAS SLIGHTLY INFERIOR. I'M NOT SURE IF THE LEFT SCREW WAS INFERIOR AS WELL BECAUSE IT WAS REMOVED BEFORE A LATERAL XRAY WAS TAKEN. THE LOCAL TEAM WANTED AN EEF FILED TO CHECK FOR ACCURACY ON THE SYSTEM AND THE CAMERA CALIBRATION. AFTER THE LEFT SCREW WAS REMOVED, WE DID A BAILOUT TO 2D NAVIGATION WITH E3D. THE SCREW FOLLOWED THE ORIGINAL SCREWS TRAJECTORY, WHICH WAS VISIBLE ON EGPS, AND THE SURGEON DECIDED TO BAIL ON NAVIGATION AND PLACE THE SCREW USING A K-WIRE AND FLUORO IMAGING. THE LOCAL TEAM ALSO WANTED TO NOTE THAT THE OFFSET METER HAS BEEN MUCH MORE SENSITIVE SINCE THE UPGRADE TO THE POINT WHERE IT'S ALMOST ALWAYS HIGH AND THEY ARE CONSISTENTLY LOSING THE GREEN BORDERS EVEN WHEN THE SCREW IS BEING PLACED ACCURATELY.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING A SINGLE POSITION LATERAL CASE (L2-L5 PRE-OP WORKFLOW WITH E3D), MERGE WAS UNSUCCESSFUL MULTIPLE TIMES LEADING TO AN ABORTED CASE. DURING THE FIRST ATTEMPT, CENTROIDS APPEARED LATERAL THE ON THE MERGE ITSELF IN THE A/P VIEW. THE CENTROIDS WERE NOT EVEN REMOTELY CLOSE TO THEIR CORRESPONDING VERTEBRAE. NEW IMAGES WERE TAKEN, LEVELS WERE CHECKED AND CONFIRMED TO BE CORRECT BY USING THE SACRUM AS A GUIDE, AND CENTROIDS WERE CONFIRMED TO BE PLACED IN THE CENTER OF THE VERTEBRAE AS THEY ARE SUPPOSED TO BE. THE SECOND ATTEMPT OF THE MERGE WITH ADDITIONAL IMAGES TAKEN SHOWED THE CENTROIDS TO BE CENTERED, BUT THE SPINAL COLUMN APPEARED TO BE INVERTING/MOVING QUITE A BIT. A THIRD ATTEMPT WAS DONE WITH COMPLETELY NEW IMAGING, BUT AGAIN WAS UNSUCCESSFUL. WE BELIEVE THERE IS AN ISSUE WITH MERGING IMAGES TAKEN BY THE E3D TO A CT COMPLETED OUTSIDE THE HOSPITAL BEFORE THE CASE STARTED. WE ARE UNSURE WHY THE CENTROIDS WERE NOT CENTERED ON THE FIRST IMAGE, AND ALSO UNSURE BY THERE WAS SO MUCH MOVEMENT OF THE VERTEBRAE WHEN NEW IMAGING WAS DONE.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING A ROBOTIC PROCEDURE, THE SYSTEM BEGAN LAGGING CAUSING NAVIGATION TO BECOME SLOW AND CHOPPY. THE FIRST TIME, A HARD SHUTDOWN RESOLVED THE ISSUE. THE FIRST STAGE OF THE PROCEDURE WHICH WAS INTRA-OP WORKFLOW. NEAR THE END OF THE SECOND PORTION OF THE PROCEDURE, THE SOFTWARE BEGAN TO LAG AGAIN RESULTING IN THE SURGEON BAILING ON THE ROBOT TO COMPLETE THE CASE WITH FLUOROSCOPY.

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 USING THE EXCELSIUS GPS SYSTEM WAS MISPLACED INTRA-OPERATIVELY CAUSING A CSF (CEREBRAL SPINAL FLUID) LEAK. THIS EVENT OCCURRED IN GERMANY.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: WE EXPERIENCED 3 MISSED SCREWS DURING A CASE.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: WHEN MAKING A SCAN TO VERIFY THE SCREW PLACEMENT WE NOTICED A MEDIAL BREACH OF THE L4 SCREW ON THE RIGHT SIDE, WHEN DOING THE DECOMPRESSION, WE ALSO SAW THE BREACH. SCREW WAS TAKEN OUT AND REPOSITIONED USING FREE HAND STEALTH NAVIGATION. L4 SCREW ON THE LEFT A LITTLE MORE LATERAL THAN PLANNED. L5 SCREWS ARE OK. WE STARTED WITH THE L4 SCREW ON THE LEFT SIDE, THEN L4 RIGHT FOLLOWED BY L5 RIGHT AND LAST L5 LEFT. WE DIDN'T GET ANY MESSAGES INDICATING THERE WAS A SHIFT.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: PROCEDURE WAS A L2-L4 LUMBAR FUSION. BEGINNING OF THE CASE WAS NORMAL: INTRAOP WORKFLOW WITH E3D. DRB WAS PLACED IN THE R PSIS, AND SURVEILLANCE MARKER PLACED IN L PSIS (SUCCESSFULLY ACTIVATED). SET UP, IMAGING, AND PLANNING OF THE SCREWS ALL COMPLETED WITHOUT ANY ISSUES. HOWEVER, WHEN MOVING THE ROBOT WITHIN NAVIGATION RANGE, SURGICAL TEAM MOVED EE VIA BRACELET INTO THE DRB, CAUSING IT TO VISIBLY SHIFT. HOWEVER, UPON REPOSITIONING OF THE ARM, DRB APPEARED TO MOVE BACK INTO ORIGINAL LOCATION. THE POST IN THE PSIS WAS CHECKED, AND APPEARED STABLE. FOLLOWING THIS, LANDMARK CHECKS WERE COMPLETED AND IT WAS DECIDED THAT ANATOMY/NAVIGATIONAL INTEGRITY APPEARED ACCURATE. FOLLOWING PLACEMENT OF ALL 6 SCREWS, 1 SCREW (R L2) WAS FAR TOO LATERAL, AND THE DECISION WAS MADE TO REMOVE THE SCREW AND NAVIGATE A NEW SCREW. A SECOND CASE WAS MADE, AND THE POST-OPERATIVE E3D SPIN WAS USED FOR A PRE-OP PROTOCOL. MERGE WAS SUCCESSFUL, HOWEVER THE SCREW PLACEMENT WAS AGAIN LATERAL. WE ARE CERTAIN THERE WAS A DRB SHIFT DURING THE FIRST PORTION OF THE CASE, CAUSING THE SCREWS TO APPEAR LATERAL. HOWEVER WE ARE UNSURE AS TO WHY THE REPLACEMENT SCREW WAS ALSO LATERAL. OUR THOUGHT IS THAT IT MAY HAVE SLID IN

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ROBOT WAS USED FOR CASE THIS AM WITH DR. (B)(6) WITH NO ISSUES. ROBOT WAS THEN MOVED TO ROOM ACROSS THE HALL FOR USE WITH DR. (B)(6). UNPLUGGED AND REPLUNGED INTO THE NEW ROOM, IN THAT TIME THE BATTERY WAS NO LONGER SHOWING AS BEING PLUGGED IN. THEY TRIED MULTIPLE OUTLETS AND HARD RESTARTS TO NO AVAIL. THEY ARE LOOKING FOR A RESOLUTION AS SOON AS POSSIBLE, BUT LIKELY WILL BAIL ON CURRENT CASE. LIKELY NEED A FUSE REPLACEMENT.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: WHILE THE ARM WAS MOVING TO NEW TRAJECTORY WE RECEIVED THE YELLOW ERROR MESSAGE THAT SAID THAT WE WERE APPLYING TOO MUCH FORCE ON EE, AND THE ARM STOPPED MOVING.THE SURGEON CANCELED THE MESSAGE AND TRIED TO REACH THE TRAJECTORY BY PRESSING ON THE PEDAL MULTIPLE TIMES BUT WE ALWAYS RECEIVED THE SAME ERROR MESSAGE.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE ROBOT IS FAILING TO COMMUNICATE WITH C-ARM. ALL FIELD TROUBLESHOOTING HAS FAILED.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE ROBOT HAS HAD 4 MISPLACED SCREWS IN THE LAST WEEK.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AT 8:45AM THE ROBOT WAS PLUGGED IN AND TURNED ON. EVERYTHING SEEMED TO BE WORKING FINE. ROBOT WAS LEFT ON AND PLUGGED IN. 11:15AM ROBOT WAS ROLLED INTO SURGERY ROOM 5 AND PLUGGED IN. A O-ARM SPIN WAS COMPLETED AND THE SCAN WAS LOADED AS A PRE-OP CT. SCAN WAS LOADED TO THE ROBOT WITH NO ISSUES, AND SCREWS WERE PLANNED ACCORDING TO LEVEL AND BILATERAL ORIENTATION. SURGEON THEN BEGAN TO FINE TUNE THE SCREWS, AND AT THIS POINT THE MONITOR SHUT OFF AND MONITOR LIGHT TURNED RED, A BLUE TEXT BOX APPEARED SAYING "NO SYNC". THE SCREW BEGAN TO REBOOT GOING THROUGH NORMAL BOOTING SCREWS AND THEN TO LOGIN SCREEN, AS THE SCREEN WAS REBOOTING THE MONITOR LIGHT WAS BLUE. WE LOGGED BACK IN AND THE SURGEON BEGAN FINE TUNING, THEN IT SHUT DOWN AGAIN. AT THIS POINT I CHANGED THE OUTLET THAT THE ROBOT WAS PLUGGED INTO AS IT REBOOTED. I NOTICED THAT THE FANS WERE TURNING OFF THEN BACK ON DURING THE REBOOTING PROCESS. ONCE REBOOTED AND PLAN PULLED UP WE RECEIVED A "MOTION COMMUNICATION ERROR" WE CLICKED OUT OF IT AND STARTED TO FINE TUNE AGAIN. THE SURGEON WAS ABLE TO GET A WHOLE LEVEL DONE AND THEN IT DID IT AGAIN. WE TRIED ONE MORE TIME BEFORE IT REBOOTED A SURGEON DECIDED TO BAIL ON THE ROBOT.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: WHEN REGISTERING T12, C-ARM SHOTS WERE NOT ALIGNING WITH PREOP SEGMENT OF THE PATIENT'S BODY ALTHOUGH MERGE SCORES WERE ACCEPTABLE.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: CASE AT (B)(6) WAS A L4/L5 OPEN TLIF WITH CREO AMP USING THE PREOP WORKFLOW ON AN EGPS SYSTEM THAT IS RUNNING SPINE 1.4. EXPOSURE WAS MADE AND DRB WAS PLACED ON A SPINOUS PROCESS CLAMP AT L3 WITH THE CAMERA AT THE HEAD. SURVEILLANCE WAS PLACED IN LEFT PSIS. FLOURO IMAGES WERE ACQUIRED FOR REGISTRATION AND DUE TO SOME PRIOR ISSUES WITH THE MERGE, CAREFUL ATTENTION WAS PAID TO GETTING MORE TRUE IMAGES AND ALSO TO KEEP THE DRB AS MUCH OUT OF THE SHOTS AS POSSIBLE AS TO NOT INTERFERE WITH THE FIXTURE BBS. AFTER THE MERGE WAS RUN, IT WAS DETERMINED THAT AT L4 THE WAS SOME ANTERIOR POSTERIOR SHIFT IN THE LATERAL. ANOTHER REGISTRATION TYPE WAS SELECTED AND DEEMED SATISFACTORY. DUE TO THE INCISION, DR. (B)(6) ELECTED TO START AT L4 AND WORKED TOWARD L5. THE LAST SCREW PLACED WAS L5R AND A LOT OF RETRACTION WITH A VERSATRAC WAS USED TO BE ABLE TO PLACE SCREW INSIDE THE INCISION. UNFORTUNATELY DO THE WORKFLOW AND ROOM SET UP, SURVEILLANCE WAS UNABLE TO BE SEEN. UPON XRAY CONFIRMATION SHOTS, IT WAS DETERMINED THAT THE L5R SCREWS WAS LATERAL TO THE PLAN. THE SCREW WAS REMOVED, AND AN ACCURACY CHECK WAS PERFORMED AND DEEMED SATISFACTORY. THE SCREW WAS REINSERTED UNDER A NEW PLAN AFTER FREE HAND

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A PRE-OP BASED L3-L5 OPEN CASE WAS BEING PERFORMED AND THE MERGE LOOKED GOOD BY VERIFYING THE ANATOMICAL LANDMARK. AS IT WAS AN OPEN CASE, SURGEON HAS NOT USED SM TO AVOID AN ADDITIONAL INCISION/FIXATION ON PSIS. AFTER PLACING ALL THE SIX SCREWS A POST OP XRAY HAS BEEN TAKEN. FIRST SCREW I.E. L3-L WAS NOT PLACED AS PER THE PLAN AND ENTERED INTO L2-L3 DISK. THERE WAS NO ADVERSE EFFECT TO PATIENT AND THE SCREW WAS CORRECTED MANUALLY. REST ALL OTHER SCREWS WERE FINE.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE ROBOT HAS HAD MULTIPLE DIFFERENT FAILURES OF THE STABILIZER ENGAGEMENT.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: PROCEDURE WAS A PREOP CT T9 TO THE PELVIS. THE CASE WAS STAGED WITH THREE LEVELS OF LATERAL FROM L1-L4 COMPLETED THE DAY PRIOR, A PREOP CT TAKEN AND THEN AN ALIF AT 5-1 THE DAY OF THE POSTERIOR PORTION. AFTER THE ALIF, PATIENT WAS FLIPPED, AND A SMALL SKIN LEVEL INCISION WAS MADE FROM T9 TO THE PELVIS - NOT MUCH EXPOSURE WAS PERFORMED AS THE SCREWS WERE GOING TO BE INSERTED USING CREO MIS. FLOURO IMAGES WERE ACQUIRED, AND THE MERGE WAS ACCURATE AT ALL LEVELS EXCEPT FOR L4. NEW IMAGES WERE ACQUIRED, AND THE MERGE WAS RERUN WHICH IMPROVED AT L4. WE BEGAN INSERTING SCREWS AT T9 AND SNAKED DOWN TO THE PELVIS. IN THE PELVIS WE WERE GOING TO BE PLACING TWO CREO S2AI SCREWS AND TWO MEDIAL TO LATERAL SI LOK SELECT SCREWS. THE ORDER IN WHICH THEY WERE PLACED WAS CREO S2AI LEFT, SILOK SELECT LEFT, CREO S2AI RIGHT, SILOK SELECT RIGHT - DUE TO THE DRB BEING PLACED IN RIGHT PSIS ON LOW PROFILE QUATTRO SPIKE. FLOURO IMAGES WERE TAKEN, AND ALL THE SCREWS SEEMED TO BE PLACED CORRECTLY. DR. (B)(6) THEN PROCEEDED TO DROP THE RODS AND AFTER THIS WAS COMPLETED, WE ACQUIRED TWO O ARM SPINS TO CHECK ALL OF THE INSTRUMENTATION. AFTER REVIEW OF SCANS, ALL SCREWS WERE PLACED ACCURATELY EXCEPT FOR S2AI ON T

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS AN INTRAOP CASE WITH ZIEHM 3D, SOFTWARE 1.1R3. THE SCAN WAS TRANSFERRED WITH THE USB, UNFORTUNATELY, WE DIDN'T GET AUTOMATIC REGISTRATION AND DID IT MANUALLY. THE ANATOMICAL LANDMARK CHECK HAD BEEN DONE. THE ACCURACY WAS GOOD. THE FIRST SCREW L5-L WAS PLACED WITH GOOD NAVIGATION ACCURACY. BY THE SECOND SCREW L5-R, EE WAS ON THE TRAJECTORY, WITH A GREEN BORDER AND OFFSET. UNFORTUNATELY, WE COULD NOT SEE THE HIGH-SPEED DRILL INSIDE THE EE. THE TOOL WAS VISIBLE TO THE CAMERA OUTSIDE THE EE. THE SURGEON CHECKED THE NAVY ACCURACY, IT WAS NOT ACCURATE ANYMORE. THE SURGEON PLACED THE SCREWS IN THE TRADITIONAL WAY.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS WE ATTEMPTED TO SEND THE CT SCAN, WE GOT A "CAMERA DISCONNECTED ERROR," EVEN THOUGH CAMERA WAS PLUGGED IN. WE ALSO GOT A "UAIB VERSION OUTDATED ERROR" MESSAGE WHILE TRYING TO RECEIVE A SCAN. THE CAMERA THEN STOPPED BEING ABLE TO PICK UP END EFFECTOR ON THE VERIFY PAGE.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THIS WAS A L4-S1 PERC WITH SCREWS BACKING UP AN OLIF. THEY FLIPPED PATIENT FROM LATERAL TO PRONE AND THEN DID A E3D SPIN. NO ISSUES WITH THE SPIN, HOWEVER THE IMAGE QUALITY WASN'T GREAT AND MADE IT DIFFICULT TO SEE ANATOMY. RUSSELL AND THE PA PLANNED THE INITIAL SCREW TRAJECTORIES AND THEN DR. WILLIAMS CAME OVER AND MADE FINAL ADJUSTMENTS TO THE PLAN. HE STARTED WITH L4-LEFT, THEN HE PLACE L4-RIGHT. HE THEN PLACED L5-RIGHT, HE NOTICED THAT THE MIS TOWER WAS SIGNIFICANTLY LOWER THAN HIS L4-RIGHT TOWER. HE OBTAINED A GREEN CHECK MARK FOR ALL OF HIS SCREWS AND DID NOT GIVE ANY EXTRA ROTATIONS AFTER THE GREEN CHECK MARK. WE WERE NOT SURE WHY THIS WAS THE CASE. BEFORE PROCEEDING, WE WENT AND LOOKED AT THE PLAN AND THE PLAN SHOWED THAT 4 AND 5 SHOULD HAVE HAD THE SAME HEIGHT AND DEPTH. ONCE ALL THE SCREWS WERE PLACED, WE TOOK CONFIRMATION SHOTS WITH THE C-ARM. DR. WILLIAMS THEN POINTED OUT TO US THAT THE L5-RIGHT SCREW WAS ABOUT A CM LOWER THAN L4. HE THEN BACKED OUT THE L5 SCREW TO BE MORE IN LINE WITH HIS L4 SCREW. HE PLACED 6 SCREWS IN TOTAL AND 5 OF THE 6 SEEMED TO BE AT THE APPROPRIATE HEIGHT/DEPTH. DR. WILLIAMS WANTS TO KNOW WHY THE L5-RIGHT SCREW WAS PLACED LOWER THAN WHAT HIS PLA

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 AFTER A SURGERY ON (B)(6) 2023 UTILIZING THE EXCELSUS GPS THE PATIENT EXPERIENCED EXTREME PAIN AND DECREASED MOVEMENT IN THEIR LEGS. ON (B)(6) 2023 MRI SCANS REVEALED A COMPRESSION FRACTURE OF T10. REVISION WAS PERFORMED URGENTLY TO DECOMPRESS THE SITE AND REVISE THE HARDWARE SURROUNDING IT.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE EGPS UNIT WILL NOT POWER ON. EITHER THE POWER CABLE OR WHERE IT CONNECTS TO THE UNIT IS DAMAGED. A CASE COULD NOT BE PERFORMED WITH THE ROBOT TODAY BECAUSE OF THE ISSUE. IT HAD TO BE COMPLETED UNDER 2D FLUORO WITHOUT THE EGPS.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE DOCTOR INSERTED HIS LAST SCREW THEN CAPTURED FLUORO SHOTS. FLUORO AND STIMMING THE SCREW PROVED IT WAS INFERIOR OF THE PLANNED POSITION. THE DOCTOR REMOVED THE SCREW AND THEN RE-IMPLANTED IT WITH A JAMSHID-K-WIRE.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ROBOT CAMERA DISPLAYED HARDWARE BUMP PERFORMED MERGE VERIFIED ALL INSTRUMENTS INCLUDING EE. SUCCESSFUL MERGE, WHEN WE WENT TO PLACE IMPLANTS, SURGEON WAS UNABLE TO SELECT LEVEL AND GUIDE ROBOT TRAJECTORY. SURGEON ABORTED ROBOT PROCEDURE.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: HAD A GOOD MERGE WITH 0 SHIFTS. WHEN LANDING END EFFECTOR ON TRAJECTORY THE INSTRUMENTS ON THE SCREEN WERE NOT MATCHING WHAT THE WE WERE SEEING LIVE ON THE PATIENT. REIMAGED THE PATIENT AND STILL HAD NO SHIFT. NAV STILL LOOKED OFF AT THE TOP OF THE CONSTRUCT BUT DEAD ON LOWER SCREWS. STILL MISSED OUR L5 RIGHT SCREW. SENDING LOGS.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: HAD A GOOD MERGE WITH 0 SHIFTS. WHEN LANDING END EFFECTOR ON TRAJECTORY THE INSTRUMENTS ON THE SCREEN WERE NOT MATCHING WHAT THE WE WERE SEEING LIVE ON THE PATIENT. REIMAGED THE PATIENT AND STILL HAD NO SHIFT. NAV STILL LOOKED OFF AT THE TOP OF THE CONSTRUCT BUT DEAD ON LOWER SCREWS. STILL MISSED OUR L5 RIGHT SCREW. SENDING LOGS.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IDENTIFIED AS L1-L3 BY SURGEON, REP, AND CSR. CENTROIDS WERE PLACED ON THE L1-L3 LEVELS AND A MERGE WAS RUN. THE SURGEON, REP, AND CSR REVIEWED THE MERGE AND VERIFIED THE LEVELS TOGETHER. FOLLOWING PLACEMENT OF SCREWS AT L1, SURGEON NOTED NAVIGATION WAS NO LONGER ACCURATE. WE REIMAGED THE PATIENT BEFORE PLACING SCREWS AT L3. FLUORO WAS USED TO CONFIRM SCREW PLACEMENT, BUT IT WAS NOTED THAT THE RIGHT L3 SCREW WAS MEDIAL TO WHAT WAS PLAN. THE SCREW STIMULATED AT 9MA, PER NEUROMONITORING TECH. THE SURGEON REMOVED THE SCREW AND DECIDED TO REPLACE IT FREEHAND USING FLUORO ASSISTANCE. ALL SCREW PLACEMENT WAS CONFIRMED WITH FINAL FLUORO IMAGES.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AFTER THE SCREWS WERE PLACED, ALL OF THE LUMBAR SCREWS AND S2AIS LOOKED GOOD ON THE IMAGES, BUT WE NOTICED THAT ALL OUR SILOK SCREWS LOOKED LIKE THEY WERE BURIED TOO DEEP.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE CASE WAS AN INTRAOP (O-ARM) L4-L5 TLIF EXTENSION OF EXISTING L5-S1 TLIF WITH REMOVAL OF L5-S1 SCREWS AND RODS. INTRAOP WITH CREO 5.5 SCREWS. FIRST DR (B)(6) OPENED UP THE PATIENT AND REMOVED THE EXISTING MATERIAL, THEN PLACED DRB AND SM ON PSIS. SM WAS ACTIVATED, SCOUT SHOTS WERE TAKEN, APNEA WAS INITIATED, SNAPSHOT AND SCAN WERE TAKEN. DURING SCAN TRANSFER, ANEA WAS APPLIED ONCE MORE. NOTHING WAS MOVED BEFORE THE SCAN WAS AUTO REGISTERED. DRB SHIFT WAS SHOWN WHILE TRANSLATING THE OR TABLE OUT OF THE O-ARM LUMEN BUT DISAPPEARED ONCE PATIENT WAS FULLY BACKED OUT AND SM TURNED GREEN. SCREW PLANNING WAS DONE (PEDICULE SCREWS). WE NOTICED THAT TWO "TRAJECTORIES" WERE HIGHLIGHTED IN THE 3D VIEW. WHEN MOVING THE ROBOT TO THE OR TABLE, THE CAMERA WENT DEAD. THE CAMERA COULD NOT SEE ANYTHING ANYMORE (NO DRB, NO EE, NO INSTRUMENTS) AND THE ARM MOVEMENT WAS FROZEN. THE ARM COULD NOT BE MOVED, NEITHER BY THE BUTTONS ON THE CP, NEITHER BY THE FOOTSWITCH OR BRACELET. I SWITCHED TO CRANIAL AND BACK, WHICH UNLOCKED THE CAMERA AND THE ARM MOVEMENT. WHEN DRILLING FIRST SCREW DEFLECTION WAS NOTICED, BUT DRILLED TRAJECTORY WAS COMPLETELY LATERAL OF THE PLANNED ONE (VERIFIED WITH FEELER). SURGEON

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: WHILE DOING AN INTRAOPERATIVE WORKFLOW, WERE ABLE TO SUCCESSFULLY DO A SPIN BUT NAVIGATION WAS OFF BY APPROXIMATELY 5 MM IN THE SUPERIOR DIRECTION AND A SCREW WAS MISPLACED. THEY THEN DECIDED TO RESIGN BUT UPON REBOOT E3D REQUIRED A FULL REHOMING. AFTER A FULL REHOMING THEY DID ANOTHER SPIN AND NAVIGATION WAS ACCURATE.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: FUSES NEED REPLACING FOR EXCELSIUS GPS.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AFTER MERGING THE PREOP CT TO THE FLUOR SHOTS, WE ATTACHED THE EE TO THE ARM AND ATTEMPTED TO VERIFY IT BEFORE STABILIZING THE ROBOT FOR TRAJECTORY. ALTHOUGH THE EE WASN'T SEEN ON SCREEN, IT STILL VERIFIED WHEN THE TECH PLACED AN INSTRUMENT INTO IT. ON THE NAVIGATION PAGE THE CAMERA WAS ONLY SEEING THE DRB AND SURVEILLANCE BUT NOT THE EE. TRIED TAKING IT OFF/PUTTING IT BACK ON, RESETTING THE SOFTWARE, SWITCHING BACK AND FORTH FROM CRANIAL, AND RESTARTING THE SYSTEM. ALSO TRIED A DIFFERENT EE. SURGEON DECIDED TO DO THE XLIF FIRST, AND WHILE HE WAS PERFORMING THE XLIF WE WERE ABLE TO GAIN VISUALIZATION OF THE EE WITH THE ROBOT PULLED BACK/AWAY FROM THE PATIENT. POST XLIF, WE RE-MERGED WITH "ADDED HARDWARE" AND BROUGHT THE ROBOT BACK IN. THIS TIME THE EE WAS GOING IN AND OUT OF VISUAL RANGE. THE EE WOULD TRAVEL TOWARDS A TRAJECTORY AND STOP SHORT SHOWING A CYCLE OF BLANK/GREEN/YELLOW. TRIED REPOSITIONING THE DRB AND REMERGING WITH A DIFFERENT EE. SURGEON DECIDED TO DO THE SCREWS FREEHAND WITH FLUORO.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DR. (B)(6) ROBOT CASES. 2 DIFFERENT ROBOTS. BOTH PRE-OP CT CASES. T10-ILIUM. WE ARE PUTTING X2 SI-LOK SELECT SCREWS AT THE BOTTOM OF THE CONSTRUCT IN THE BEDROCK TRAJECTORY. FIRST CASE WAS ON 5/16. WE SELECTED LEFT SIDE FIRST. DRILL WAS ACCURATE. AND WE PROCEEDED TO PUT THE LEFT SCREW IN UNTIL WE GOT A CHECK MARK. DR. (B)(6) FELT SOMETHING WAS WRONG. RIGHT SIDE WENT FINE.UPON X-RAY THE LEFT SIDE WAS DEEP ABOUT AN INCH. PUT THE NAV DRIVER BACK ON TO BACK UP SCREW AND IT NOW SHOWED AN INCH DEEP AS IT DID NOT BEFORE. SECOND CASE 5/31 SAME EXACT THING HAPPENED HOWEVER WE CAUGHT IT BEFORE PROCEEDING TO PUT IN THE SCREW. BOTH INSTANCES THE RIGHT-SIDE NAV WAS ON. IT WAS ONLY LEFT SIDE THAT WE SELECTED FIRST. PLEASE CALL ME FOR MORE DETAILS ON HOW WE TROUBLESHOOTED IT AND ON MY THEORY OF WHAT HAPPENED. ALL CASES AND LOGS ARE UPLOADED.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AFTER IMPLANTING THE SCREW, THE DEFLECTION METER WAS TRIGGERED SHOWING THE SCREW INFERIOR OF THE INTENDED PLAN. UPON MOVING TO L5L ANOTHER LM CHECK WAS SUGGESTED AND NAVIGATION AT THIS POINT BUT STILL LOOKED ACCURATE AS THE CROSSHAIRS WERE INTERSECTING BONE ON AXIAL AND SAGITTAL VIEWS. AFTER USING THE HS DRILL AND PILOT DRILL THE DOCTOR WAS CONCERNED. I HAD NOTICED THE SOUND OF THE DRILLS GOING THROUGH THE LAYERS OF CORTICAL BONE WASN'T REFLECTING WHAT WE WERE SEEING ON THE NAVIGATION. THE DOCTOR IMMEDIATELY CALLED FOR X-RAY AND PUT THE VERIFICATION PROBE INTO THE HOLE HE PREPPED FOR L5L. THE C-ARM WAS BROUGHT IN AND AP/LAT SHOTS SHOWED EACH SIDE WAS SYMMETRICAL BUT 5MM INFERIOR OF THE PEDICLE. THE L5R SCREW WAS REMOVED. WE BAILED TO PRE-OP CT WORKFLOW WITH E3D.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A SCREW WAS MISSED SUPERIORLY AT L5R. THIS WAS THE SECOND SCREW OF THE CONSTRUCT, AND THE OTHER SCREWS WERE PROVEN TO HAVE CORRECT PLACEMENT WITH FLUORO SHOTS. THERE WAS AN AIR BUBBLE IN THE PEDICLE, AND SOME DEFLECTION WAS SHOWN. A CHECKMARK WAS GIVEN BY THE SOFTWARE WHEN THE SCREW WAS PLACED INITIALLY. FLUORO SHOTS WERE TAKEN AFTER ALL 6 TRAJECTORIES WERE COMPLETED, AND THE L5R SCREW WAS PULLED OUT.