ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: GPS UNIT IS HAVING HARD DRIVE ISSUES. IT WILL ONLY DISPLAY A BLACK SCREEN WHEN BOOTING UP STATING "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: 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: THE CASE WAS AN L4-S1 ALIF 360 USING HEDRON IA AND CREO ONE HARDWARE. THERE WAS NO PRIOR HARDWARE IN THE PATIENT. THE EGPS WORKFLOW WAS INTRA-OP CT. THE EGPS IS RUNNING SOFTWARE VERSION 1_1R3. THE PATIENT WAS POSITIONED PRONE FOR THE POSTERIOR PORTION AND THE CAMERA WAS POSITIONED AT THE FOOT OF THE BED. AN O-ARM WAS USED FOR IMAGING AND REGISTRATION. DR. (B)(6) PLACED THE DRB AT RIGHT PSIS WITH THE LOW-PROFILE QUATTRO SPIKE AND SURVEILLANCE MARKER AT LEFT PSIS. SURVEILLANCE WAS REGISTERED PRIOR TO THE ICT BEING POSITIONED ON THE QUATTRO SPIKE. THE ICT WAS POSITIONED, THE BED WAS RAISED, AND THE SURGICAL SNAPSHOT WAS TAKEN. THE O-ARM SPIN WAS ACQUIRED AND TRANSFERRED SUCCESSFULLY TO EGPS VIA ETHERNET. ALL 7 FIDUCIALS WERE CAPTURED SUCCESSFULLY, AND THE REGISTRATION FIT WAS DOWN ON GREEN. DR. (B)(6) PERFORMED LANDMARK CHECKS ON THE ICT FIDUCIALS AS WELL AS DOWN THE LOW-PROFILE QUATTRO SPIKE. NAVIGATION APPEARED TO EVERYONE IN THE ROOM TO BE ACCEPTABLE AND OF HIGH QUALITY. FOLLOWING PERCUTANEOUS PLACEMENT OF ALL SCREWS THROUGH BILATERAL WILTSY INCISIONS, A POST-OP REGISTRATION O-ARM SPIN WAS ACQUIRED. DR. (B)(6) DECIDED TO DO THIS PRIOR TO LOCKING THE CONSTRUCT DOWN AS HE QUESTIONED

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE SURGEONS COMPLAINT WAS THE FACT THAT WHILE ATTEMPTING TO MERGE THE L2 VERTEBRAL BODY, HE WAS UNABLE TO GET A BETTER MERGE BECAUSE OF THE LORDOTIC SHIFTING.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: WE WERE INSTRUMENTING PEDICLE SCREWS AT T12 & L2 , SKIPPING THE FRACTURE LEVEL. THE E3D SPIN WENT FINE, AND INITIAL NAV INTEGRITY CHECKS SEEMED FINE AS WELL. WE PLACED ALL 4 SCREWS AT T12 / L2. WE BATTLED A LITTLE BIT OF SAVING BUT NOTHING SIGNIFICANT. WE TOOK AP SHOT AFTER SCREWS WERE PLACED, AND ALL FOUR SCREWS WERE COMPLETELY OUT OF THE PEDICLE. THE LEFT SIDE WAS LATERAL, AND RIGHT SIDE WAS MEDIAL.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ALL OUR SCREWS WERE ON, WE USED PRE OP CT WORKFLOW WITH G-ARM. THEN WE TOOK AN X-RAY OF OUR LATERAL TRIAL, AND THE NAVIGATION WAS ON. WHEN PLACING THE IMPLANT, WE WERE 4/5MM OFF POSTERIOR. WE HAD TO GO BACK IN, OPEN THE PATIENT, RETRIEVE THE CAGE AND RE DO EVERYTHING, NAVIGATION APPEARED TO BE ON UP UNTIL THE CAGE.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: APOLOGIES, ORIGINAL REPORT DID NOT PROCESS. LOGS HAVE BEEN UPLOADED TO INR PORTAL. THERE WAS A SUSPECTED ISSUE WITH THE PREOP REGISTRATION/MERGE. T12 FRACTURE, SCREWS PLACED AT T10-11, L1-2. NAMELY, T11-L WAS PLACED LATERAL TO THE ORIGINAL PLACE. ADDITIONALLY, T10 SCREWS PLACED PROUD. AFTER DISCUSSION, SUSPECTED MISSTEP MAY HAVE BEEN PROPER PLACEMENT OF FLUORO FIXTURE BUT NO YET CAUSE DETERMINED. SCREWS WERE REPOSITIONED VIA TRADITIONAL MIS JAMSHID TECHNIQUE.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE PLANNED SURGERY ON THE DORSAL CERVICAL SPINE INCLUDED A SCREW FIXATION C1/C3/C4. WHEN CHECKING THE SCREW POSITION IN THE 3D SCAN AFTER SCREW PLACEMENT, THE SURGEONS WERE NOT SATISFIED WITH THE SCREW POSITION OF A C1 SCREW. A NEW 3D SCAN WAS PERFORMED AND A NEW C1 SCREW WAS PLANNED INTRAOPERATIVELY. WHEN APPROACHING THE TRAJECTORY, THE ROBOTIC ARM STOPPED FAR AWAY FROM THE FINAL POSITION AND ONLY SHOWED A YELLOW FRAME. THE END EFFECTOR WAS SO FAR AWAY THAT THE INSTRUMENTS DID NOT REACH THE BONE. RESETTING THE SOFTWARE AND MOVING THE ROBOT ARM MANUALLY DID NOT CHANGE ANYTHING. BECAUSE THE ROBOT ARM WAS TOO FAR AWAY, THE C1 SCREW HAD TO BE INSERTED MANUALLY (WITH NAVIGATION OF THE ROBOT), BUT NOT BY THE END EFFECTOR.

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 SCREW TO BREACH THE PATIENT'S SPINAL CANAL.

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: CAMERA IS BROKEN FULL DESCRIPTION ENTIRE SYSTEM NEEDS TO BE RUN FOR BUGS CAMERA IS BROKEN STORAGE IS LOW AND COMPUTER IS SLOW NEED TO BE DONE ASAP.

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: TRYING TO START A CASE AND THE ROBOT WENT TO REBOOT AND SELECT PROPER BOOT DEVICE. NEED AN FSE FOR TOMORROW'S CASE WITH A NEW SURGEON.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING ROBOTIC REGISTRATION THE FLUORO SHOTS AND PRE-OP CT SCAN DID NOT ALIGN PROPERLY. WITH CLEAR FLUORO PHOTOS IT LOOKED AS IF THE ROBOT WAS PULLING AN OBLIQUE CT SLICE. WE HELD RESPIRATION, CENTERED EACH VERTEBRAE, SOFTWARE RESET, SWITCHED TO CRANIAL AND BACK WITH NO SUCCESS. I USED LIFE SAVER, BUT AT THAT POINT DR. (B)(6) CHOSE NOT TO CONTINUE WITH THE ROBOT.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS THE INTRA-OP SPINE CASE. UNFORTUNATELY, THE TEAM COULDN'T GET THE AUTOMATIC REGISTRATION. IT HAD BEEN DONE ANOTHER SCAN WITH THE SAME RESULT. AFTER THE REGISTRATION WAS DONE MANUALLY, THE SURGEON NOTICED SOME NAVIGATION SHIFTS. THE ROBOTIC CASE WAS ABORTED AND DONE TRADITIONALLY. NO ADVERSE EFFECTS FOR 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 WHILE USING THE EXCELSIUS GPS SYSTEM, THE CASE WAS ABORTED DUE TO HARDWARE ERROR. THIS EVENT OCCURRED IN THE UNITED KINGDOM.

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 LARGE BLEED.

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: IT WAS REPORTED THAT WHILE USING THE EXCELSIUS GPS SYSTEM, THE CASE WAS ABORTED AND SCREWS WERE THEN PLACED BY HAND.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ALL POWER LOST TO EGPS UNIT WHILE UNIT WAS PLUGGED INTO A VIABLE/TESTED POWER SOURCE. POWER SOURCE WAS USED IN TWO CASES DURING THE SAME DAY (B)(6) 2023. ALL FUNCTION AND AGENCY LOST TO THE EGPS UNIT DURING THIS TIME. BOTH THE BATTERY SYMBOL AND ON/OFF SYMBOL WERE NOT EMITTING ANY COLOR.

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 EVENT OCCURRED IN AUSTRALIA.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: SCREWS L2-S1, ALL LEFT SCREWS MEDIAL AND ALL RIGHT SCREWS LATERAL. WHEN REMOVING SCREWS, INITIALLY OUR SPIN WAS CORRECT AND NAVIGATION INTEGRITY WAS SOLID; HOWEVER, AFTER REMOVING ONE OR TWO MORE SCREWS, WHEN THE CHICKEN FOOT WAS AGAIN PLACED DOWN THE SCREW TRAJECTORY TO CONFIRM NAVIGATION ACCURACY, THE SCREW APPEARED TO BE MEDIAL TO WHERE THE TOOL WAS PLACED.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS NOT POSSIBLE TO UPLOAD THE PLANNED CASE FROM LAPTOP TO THE ROBOT WITH USB STICK. WE GOT THE MESSAGE ''GPS CLIENT IS NOT RESPONDING''. SOFTWARE RESET, HARD SHUTDOWN DIDN'T HELP. THE SCREEN WAS FROZEN WITH THE MESSAGE ''IMPORTING CASE FROM USB''. THE CASE WAS DONE IN TRADITIONAL 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 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 AND SCREWS WERE THEN PLACED BY HAND.

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 SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY.

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 DBS CASE AT (B)(6) MEDICAL CENTER, A 2ND O-ARM EVALUATION SPIN SHOWED THAT THE LEAD WAS ~2 MM SUPERFICIAL TO THE PLANNED DEPTH. THE PLANNED DEPTH WAS 2 MM PAST THE TARGET BASED ON THE BURNED IN BRAINLAB LEFT VIM TRAJECTORY. FROM THE FIRST EVALUATION SPIN, THE LEAD WAS 6.5 MM ABOVE THE PLANNED DEPTH AND 4.5 MM ABOVE THE BURNED IN TARGET. AFTER OBSERVING THE RESULTS FROM THIS FIRST SPIN, DR. (B)(6) STATED THAT HE MAY HAVE PULLED BACK ON THE LEAD WHEN REMOVING THE CANNULA. HE WENT BACK IN AND MANUALLY ADVANCED THE LEAD 6.5 MM FURTHER TO ACCOUNT FOR THE DEPTH DISCREPANCY WHILE HAVING HIS PA PERFORM LFPS ON THE PATIENT. AFTER HE ADVANCED THE LEAD TO HIS DESIRED DEPTH, A 2ND EVALUATION SPIN WAS PERFORMED. THE RESULT OF THIS SPIN SHOWED THAT THE LEAD WAS EXACTLY TO TARGET DEPTH, WHICH IS 2 MM SUPERFICIAL FROM HIS PLANNED DEPTH.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: FOR A SINGLE POSITION LATERAL CASE AT L4-5 DURING CASE SET UP THE END EFFECTOR LATCH WAS VERY STICKY AND HARD TO CLOSE. AFTER THE FIRST MERGE WITH PREOP CT WORK FLOW WE RECEIVED A HIGH SURVEILLANCE MESSAGE, SO WE REMERGED AND RESETTLED SURVEILLANCE. AFTER DRILLING THE FIRST PEDICLE L4 LEFT IT DID NOT FEEL OR LOOK RIGHT SO WE BROUGHT IN FLUORO. THE LATERAL WAS TO PLAN BUT THE AP WAS VERY MEDIAL. WE AGAIN REMERGED AND RESETTLED SURVEILLANCE. WE SWITCHED OUT THE END EFFECTOR AND, ON THE 3RD, TRY WE WERE ABLE TO ACCURATELY PLACE BILATERAL PEDICLE SCREWS. WE NEED TO REPLACE THE END EFFECTOR. I WILL UPLOAD CASE LOGS FOR THIS CASE TO THE ECL MODULES.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: WE PLACED QUATTRO SPIKE IN RIGHT PSIS AND SURVEILLANCE MARKER IS LEFT PSIS. WE TOOK X-RAYS FOR THE MERGE, AND ALL CONFIRMED L4 AND L5 VERTEBRAL BODIES. THE MERGE WAS SUCCESSFUL, AND X RAY CAME OUT. AT THIS POINT, THE REP HAD NOTICED THAT THE DRB ON THE LEFT WAS CLOSE TO PATIENT AND ASKED IF IT HAD BEEN LIKE THAT. I ASKED THE SURGEON IF THERE WAS A GAP, SURGEON CONFIRMED THAT THERE WAS. ROBOT WAS BROUGHT IN, AND STABILIZERS WERE PLACED. SURGEON MOVED FORWARD WITH PLACING LEFT L4, INSTRUMENTS DIDN'T LOOK RIGHT ON NAVIGATION, BUT SURGEON FELT FINE. WE DID L5 AND SAW SAME NAVIGATION ISSUE AFTER PLACING SCREW WE DECIDED TO TAKE A X RAY TO CONFIRM AND NOTICED WE WERE OFF. SURGEON THEN HAD ROBOT TAKEN OUT AND OPENED PATIENT UP. SCREWS REMOVED AND HE FINISHED THE PROCEDURE.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING A ROUTINE CASE, REGISTRATION WAS COMPLETED AND FIRST 2 SCREWS WERE PLACED SUCCESSFULLY. THIRD TRAJECTORY WAS ACTIVATED. SYSTEM GAVE ERROR "FOOTPEDAL ENABLED ERROR". USER THEN TRIED TO ACTIVATE SURGEON BRACELET AND THAT DID NOT WORK AT ALL. THAT IS WHEN THE USER DISCOVERED THE SYSTEM DID NOT HAVE ANY MOVEMENT AND THE FIRST SHUT DOWN WAS COMPLETED. THE USER LOGGED IN TOO QUICK WHEN MOTION WAS STILL BE CHECK SIGNIFIED BY BLUE INFORMATION RING. IT WAS ATTEMPTED TO CALIBRATE LOAD CELL WHICH DID NOT WORK. USER THEN PLACED REST OF SCREWS FREE HAND. SYSTEM WAS PULLED OUT OF THE FIELD AFTER THE PROCEDURE. FOOT PEDAL WAS RE-ENGAGED INTO THE PORT AND A LOAD CELL CALIBRATION WAS COMPLETED. THEY PULLED HTE SYSTEM OUT AND RESTARTED AGAIN AND MOTION WAS RESTORED.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING AN EGPS WITH E3D SINGLE LEVEL L5-S1 PERC CASE, THE TWO L5 SCREWS WERE PLACED SUPERIOR TO THE PLAN. IT IS ASSUMED THAT THE DRB WAS MOVED DURING THE CASE AND DISCOVERED THAT THE SURVEILLANCE WAS NOT SET. DURING SCREW PLACEMENT, NOTHING LOOKED UNUSUAL - DOCKING THE HIGH-SPEED BUR ON THE BONE DIDN'T SHOW THE BUR HIGH OR INTO THE BONE AS ONE WOULD EXPECT WITH A DRB SHIFT. THE SCREWS ALL STIMULATED AT 20MA EXCEPT THE RIGHT S1 WHICH WAS 10MA WHICH PROMPTED A VERIFICATION SPIN WITH THE E3D. THE L5 SCREWS AND THE RIGHT L1 WERE REMOVED AND A SECOND E3D SPIN WAS DONE. THE SCREWS WERE THEN PLACED WITH NO FURTHER DIFFICULTY. THE CASE LOG WILL BE FORWARDED.

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 L2-4 LLIF WITH POSTERIOR FIXATION USING CREO MIS AND PRE-OP CT WORKFLOW USING EGPS. THE CT SCAN APPEARED TO BE TO PROTOCOL BUT UPON MERGING THE AP AND LATERAL VIEWS APPEARED OBLIQUE AND A SUCCESSFUL MERGE COULD NOT BE OBTAINED EVEN WITH TRUE SHOTS. I AM ATTACHING CASE LOGS AS WELL AS A ZIPPED FOLDER OF THE CT SCAN SO INR APPLICATIONS MAY REVIEW THIS SCAN FOR DATA. IT CAME TO MY ATTENTION THAT THE KERNEL VALUE OF THE CT WAS B70 AND THIS IS NOT IDEAL FOR OUR PROTOCOL. THE SCANNER WAS A SIEMENS.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: L5-RT SCREW WE ACTUALLY HAD SPACE FOR A 5.5 SCREW RUNNING MEDIAL TO THE OLD SCREW AND TRIED THIS. THIS IS THE SCREW THAT ULTIMATELY LOOKED TO MEDIAL ON FLUORO AND WHEN WE DECOMPRESSED, WE COULD SEE 6 THREADS OF THE SCREW WERE MEDIAL TO THE PEDICLE WITH HALF THE SCREW EXPOSED.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MERGED CT WITH FLAT PANEL. CENTROID PLACEMENT SEEMED EXTRA OFF IN LATERAL VIEW EVEN MORE THAN USUAL. PHYSICIAN STATED THAT SOMETHING FELT OFF FROM FIRST SCREW. THROUGH 7 SCREWS PLACED, SURGEON X-RAYED AND NOTICED MULTIPLE SCREWS WERE BREACHED. NO ALARMS FROM SURVEILLANCE UNTIL THE LAST SCREW WHICH IS WHY SURGEON DID X-RAY. DID O-ARM SPIN AND NEW CASE TO REPLACE SCREWS THAT WERE BREACHED AND FINAL SCREWS.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: UPON SYSTEM BOOT UP, SYSTEM WOULD GET STUCK ON BLACK SCREEN WHERE NO BOOT MODE HAD BEEN SELECTED. THE SYSTEM WAS RESTARTED MULTIPLE TIMES AND STILL COULD NOT MAKE IT PAST THE BLACK BOOT MODE SELECT SCREEN. REQUESTING FSE SUPPORT TO ADDRESS COMPUTER/HARD DRIVES AND FIGURE OUT THE ROOT OF THIS PROBLEM.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ROBOT BROUGHT INTO ROOM AND TURNED ON WITHOUT ANY ISSUES. AFTER A COUPLE MINUTES THE SCREEN CHANGED TO A BLUE WINDOWS SCREEN STATING "YOUR PC RAN INTO A PROBLEM AND NEEDS TO RESTART. WE'LL RESTART FOR YOU." TRIED MULTIPLE RESTARTS AND ERROR STILL OCCURRED. CASE HAD TO BE ABORTED.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE SCREW PLACEMENT WAS SLIGHTLY OFF FROM THE PLAN.

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.