ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ROBOT SCREWS PLACED LATERALLY AND INFERIORLY.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: CASE WAS A L3-S2 PSF WITH EGPS AND E3D AT SARASOTA MEMORIAL WITH DR. (B)(6). DRB AND SM WERE PLACED IN CONTRALATERAL PSIS. WE RECEIVED AN ERROR STATING THAT THE DRB HINGE WAS TOO CLOSE TO THE SM (THIS ACCOUNT GETS THIS WARNING OFTEN). THIS WAS BYPASSED DUE TO THEM BEING ADEQUATE DISTANCE AWAY. SCAN WAS OBTAINED AND TRANSFERRED TO THE ROBOT WITHOUT ANY ISSUES. SCREWS WERE PLANNED BY REP (B)(6) AND DR. (B)(6). ROBOT WAS BROUGHT INTO THE FIELD. DR. (B)(6) STARTED AND L3 AND PLACED SCREWS DOWN TO S2. NAVIGATION LOOKED INTACT THROUGHOUT ENTIRE CASE. DRB WAS NOT HIT AND OFFSET WAS CONTINUOUSLY LOW. DEFLECTION STAYED IN THE YELLOW TO LOW RED RANGE DURING THE LOWER LEVELS DUE TO PATIENTS HARD SCLEROTIC BONE. DR. (B)(6) USED THE HS BURR, DRILL, BALL TIP PROBE, TAP AND DRIVER. PT HAD PREVIOUS L4-5 INTERSPINOUS PROCESS FIXATION DEVICE PRESENT THROUGHOUT THE SPIN AND SCREWS. AFTER SCREWS WERE FINISHED ROBOT WAS TAKEN OUT OF THE ROOM AND DR. (B)(6) PROCEEDED WITH THE DECOMPRESSION AND INTERBODY. FINAL SHOTS WERE TAKEN, AND IT WAS NOTED THAT RL4 WAS IN THE SUPERIOR DISC SPACE AND LL4 WAS BREACHED CAUDALLY PER DR. (B)(6). SCREWS WERE REMOVED AND NOT REPLACED. ALL OTHER SCREWS WERE IN THEIR PLANNE

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 PRE-OP CASE, T6-T10. AFTER SUCCESSFUL REGISTRATION, WE GOT ALL TRAJECTORIES IN GREEN ON THE NAVIGATION PAGE BUT THE ROBOT ARM MOVED ONLY TO T6-L. AS THE SURGEON PRESSED THE PEDAL, THE ROBOT ARM WITH EE DIDN'T MOVE TO ANOTHER TRAJECTORY, DESPITE ALL BEING GREEN. THE MESSAGE THAT WE GOT WAS-TRAJECTORY OUT OF RANGE(IN YELLOW). WE MOVED THE ROBOT MULTIPLE TIMES, BUT THE ARM MOVED ONLY TO ONE TRAJECTORY-T6-L EVERY TIME. WE DID A SOFTWARE RESET, NEW REGISTRATION, ATTACHED AND DETACHED THE EE, AND HARD SHUT DOWN, BUT IT DIDN'T HELP. THE CASE WAS ACCOMPLISHED TRADITIONALLY WITHOUT THE ROBOT.

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 PROCEDURE USING FLUORO REGISTRATION WORKFLOW ON SOFTWARE VERSION 20211.2R2P2. CASE WAS ABORTED DUE TO INABILITY TO OBTAIN AN ACCEPTABLE MERGE DURING PATIENT REGISTRATION. REQUESTING SOFTWARE INVESTIGATION TO DETERMINE WHAT WAS THE CAUSE OF THE INACCURATE MERGE ATTEMPTS.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: RIFAI (DISTRIBUTER REP) INFORMED THAT ONE CASE OF L4-L5 MIS FIXATION-INTRAOP (ALIF FIRST) WORKFLOW WAS PLANNED ON (B)(6) 2023. END EFFECTOR WAS VERIFIED WITHOUT ANY ISSUE, BUT THE EE WAS NOT GETTING DETECTED DURING NAVIGATION. TRIED TO ADJUST THE CAMERA BUT STILL NO DETECTION AND EE SYMBOL ON THE SCREEN WAS RED. FINALLY, THEY HAVE REPLACED THE EE WITH ANOTHER EE AND IT WORKED. THEY WILL UPDATE US LATER FOR THE STATUS OF FIRST EE. AFTER PLACEMENT OF ALL THE SCREWS IT HAS BEEN OBSERVED IN THE POST-OP SCAN THAT THE L4-R WAS SHIFTED LATERALLY AND L5-L WAS SHIFTED CRANIALLY FROM THE ORIGINAL PLAN. TWO SCREWS WERE REPOSITIONED MANUALLY.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: RIFAI (DISTRIBUTER REP) INFORMED THAT ONE CASE OF FRACTURE AT T7 WAS PLANNED WITH TWO INTRAOP WORKFLOW. FIRST INTRAOP WAS DONE FROM T5-T9 AND EVERYTHING WAS LOOKING GOOD TILL THE PLACEMENT OF LAST SCREW AT T9-L. SECOND INTRAOP WORKFLOW WAS DONE FROM T11-L3. IT WAS OBSERVED IN THE POST-OP SCAN THAT SCREWS AT T8 & T9 WERE SHIFTED TOWARDS RIGHT SIDE. T8-T9 LEFT SCREWS WERE ALMOST TOUCHING THE CANAL. FINALLY SCREWS AT T8-T9 WERE RE-POSITIONED MANUALLY.

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: SENT IN ROBOT CASE LOGS FROM DR. (B)(6) CASE ON 5/3. AT LEFT L4 WE REMOVED AN OLD SCREW. THE VOID CAN BE SEEN ON THE CT. A NEW TRAJECTORY WAS PLANNED AROUND THE OLD SCREW TRAJECTORY. WHEN WE PLACED THE NEW L4 SCREW ON THE LEFT THE ROBOT FOLLOWED OUR PLAN. EVERYTHING PER THE ROBOT VALIDATED OUR SCREWS PATH. WHEN WE TOOK FINAL XRAY WE SAW WE FELL INTO OLD PATHWAY.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: EGPS WAS MOVED INTO POSITION. DR. (B)(6) COMPLETED LANDMARK CHECKS BY SELECTING THE DESIRED LEVEL AND USING THE CHICKEN FOOT TO PROBE THE SPS AND LAMINAS. SCREW PREPARATION CONSISTED OF A 4.5MM HS DRILL, TIPPED QUARTEX DRILL, FOLLOWED BY THE SCREW. ONCE WE MOVED TO L5 AND CONDUCTED A LANDMARK CHECK WE REALIZED NAVIGATION WAS INACCURATE AFTER A POTENTIAL SLIGHT DRB SHIFT -SURVEILLANCE WENT UP TO 50% OR A SHIFT IN THE MERGE. IN AN ATTEMPT TO NOT HAVE TO RE-REGISTER DR. (B)(6) USED THE ADDED HARDWARE ADDED FUNCTION IN REGISTRATION AND RE-MERGED L5 THEN CONDUCTED A LANDMARK CHECK WHICH WAS ACCURATE AT THE SP. WE BELIEVE THAT DR.(B)(6) HIP BOLSTERS ON HIS CUSTOM BED IMPACT REGISTRATION DUE TO THE FAIRLY OPAQUE LINES NEAR L5 IN THE LATERAL FLUORO IMAGES. AFTER THE LANDMARK CHECK WAS CONFIRMED ACCURATE HE IMPLANTED L5. HOWEVER THE L5L SCREW WAS LOOSE SO DR. (B)(6) IMPLANTED IT FREEHAND. UPON REACHING S1 AND ILIUM WE INVERTED THE ROBOTIC ARM BUT THE VEGA CAMERA COULD NOT EASILY VISUALIZE THE END EFFECTOR FORCING US TO REARRANGE THE CAMERA STAND AND SET UP IN ORDER TO GET LINE OF SIGHT. THE CAMERA HAD TO BE PLACED NEARLY HALF WAY DOWN THE BED AND RAISED TO THE CEILING. THIS WAS NEVER AN ISS

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: SYSTEM WILL NOT CONNECT WITH CAM. ALL THESE PROBLEMS HAVE HAPPENED AFTER THE INSTALLATION OF THE NEW SOFTWARE. WE'VE HAD ISSUES ON EVERY CASE.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MONITOR TURNS OFF RANDOMLY. MOTION COMMUNICATION ERROR. SYSTEM WILL NOT CONNECT WITH CAM ORANGE INFORMATION LIGHT. ALL THESE PROBLEMS HAVE HAPPENED AFTER THE INSTALLATION OF THE NEW SOFTWARE.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: 3 MISSED SCREWS IN THIS CASE. ALL SIGNS ARE INDICATIVE OF ICT SHIFTING, BUT LANDMARK CHECKS DID NOT SHOW THAT. WE HAD ONLY A SURVEILLANCE METER SHOWING (LIKE WE ARE IN FREE HAND NAV MODE) AND NO DEFLECTION FORCE METER SHOWING. WE WERE GETTING HIGH DEFLECTION WANING ON THE SCREEN. IT SEEMED LIKE THIS WAS NORMAL DUE TO SCREW TORQUE FORCE. THE L5-R SCREW ON THE SCREEN SHOWED IT WAS PLACED TO PLAN WITH NO ISSUES. POST OP SHOTS SHOWED IT LATERAL OF THE PEDICLE. THE S1 SCREWS BOTH WERE PLACED ON THE RIGHT TRAJECTORY THAT WE HAD, BUT WERE EXTREMELY DEEP. WE STRUGGLED GREATLY AT L5-L AND DID NOT END UP PLACING THAT SCREW WITH THE ROBOT. WE BAILED TO FLUORO FOR FREE HAND SCREWS.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: WHEN MERGING TODAY THERE WAS A BIGGER SHIFT THAN NORMAL. THEY TRIED TO TAKE MULTIPLE SHOTS BUT COULD NOT CLEAR THE SHIFT THAT WAS HAPPENING.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING A PROCEDURE, WHEN READY TO ACQUIRE IMAGES FOR A REGISTRATION, SYSTEM ROI TURNED RED AND POPULATED WARNING "MOTION CONTROLLER APPLICATION TIMEOUT". MULTIPLE SHUTDOWNS WERE COMPLETED. WAITING UPWARDS OF 10 MINUTES ON THE LOG IN SCREEN. ROI WOULD BE BLUE UPON START UP AND THEN TURN RED ABOUT 2-3 MINUTES LATER.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: TODAY DR. (B)(6) WANTED TO DO ANOTHER CASE WITH THE EGPS. BECAUSE THE PLANNED CASES CANNOT BE TRANSFERRED TO THE ROBOT FROM THE LAPTOP (SEE THE LAST EEF´S) HE TOOK THE CT SCAN VROM THE PAX SYSTEM OF THE HOSPITAL. HE PLANNED THE CASE ON THE EGPS AND WANTED TO REGISTER THE PATIENT IN THE PRE-OP CT MODUS. WHEN HE TOOK THE FLUORO SHOTS TO MERGE HE COULD ONLY SEE THE LEVELS L1 TO L3 IN A CT FLIP. THE THORACIC CT SCAN WAS TOTALLY LOST, SEE ATTACHED SCREEN SHOTS. HE HAD TO ABOARD THE CASE AND THE PATIENT HAD ANESTHESIA WITHOUT A REASON, IN GERMANY THAT IS ASSAULT IF BROUGHT TO COURT, SO NOT FUN. DR. (B)(6) WILL NOT DO ANY MORE CASES UNTIL THIS PROBLEM IS SOLVED. THREE CASES FOR THIS WEEK.

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 L4-5 OPEN TLIF WITH CREO ONE AND RISE HARDWARE. THE WORKFLOW WAS BOOKED AS PREOP CT, YET AFTER MULTIPLE FAILED MERGE ATTEMPTS, AN INTRAOP CASE WAS CREATED AND THE O-ARM 2 WAS USED FOR REGISTRATION. DR. (B)(6) HAD ALREADY PLACED THE DRB USING THE REGULAR QUATTRO SPIKE AT RIGHT SIDE PSIS. THE SM WAS AT LEFT SIDE PSIS, YET IN THE RUSH TO ADAPT AND SWITCH WORKFLOWS, UNFORTUNATELY I FORGOT TO RESET IT FOR THIS CASE. I COACHED DR. (B)(6) THROUGH POSITIONING OF THE ICT FRAME ON THE QUATTRO SPIKE. I HELPED THE SCRUB REVERIFY ALL INSTRUMENTS, I TOOK THE SURGICAL SNAPSHOT, AND THE O-ARM WAS BROUGHT IN FOR REGISTRATION. O-ARM REGISTRATION WAS SUCCESSFULLY TRANSFERRED TO EGPS VIA USB. 6/7 FIDUCIALS WERE AUTO DETECTED AND VERIFIED BY ME. DR. (B)(6) CONFIRMED NAVIGATIONAL INTEGRITY THROUGH LANDMARK CHECKS WITH THE LANDMARK PROBE AFTER REMOVING THE ICT. HE THEN INSTRUMENT PLANNED ALL HIS TRAJECTORIES. DR. (B)(6) INSTRUMENTED ALL SCREWS WITH THE 4.5 HIGH SPEED DRILL, 3.5 REAMING DRILL AND CREO AMP DRIVER. THROUGHOUT NAVIGATION, I DID NOT OBSERVE ANY SPIKING IN THE DEFLECTION OR OFFSET METERS. GREEN BORDERS WERE PRESENT THROUGHOUT NAVIGATION. IT IS MY OPINION THAT DR. (B)(6) HAD VER

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: T1-T6 PSF WITH T3 CHANCE FX. USED QUARTEX EGPS SYSTEM. INTRA-OP WORKFLOW WITH O-ARM SPIN. DRB PLACED AT T7 VIA LONG SP CLAMP NO SM WAS USED. ICT WAS ATTACHED USING SECOND SP CLAMP AT T2 AND REMOVED AFTER SPIN. 10 SCREWS WERE PLACED WITH EGPS IN SNAKE PATTERN STARTING AT T1 AND SKIPPING T3. AFTER SCREWS WERE PLACED WE DID A SPIN TO CONFIRM ALL WERE IN SAFE POSITION. ALL 5 SCREWS ON LEFT SIDE WERE MEDIAL TO PLAN AND HAD TO BE REMOVED AND REPLACED. THE SCREWS WERE REPLACED VIA STEALTH NAVIGATION. SUBMITTING THE SCANS AND CASE LOGS FOR REVIEW.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: L5-S1 TLIF INTRAOP WITH CREO MIS SCREWS. EVERY STEP WAS DONE EXACTLY LIKE THE PREVIOUS CASES, EXCEPT THAT THE SM WAS NOT ACTIVATED BEFORE THE IMAGING. PATIENT WAS NOT DRAPED DURING O-ARM SCAN, BUT TABLE WAS TRANSLATED INTO THE LUMEN OF THE O-ARM. SNAPSHOT, SCAN AND TRANSFER WERE ALL DONE UNDER APNEA. AFTER THE TRANSFER THE SOFTWARE DID NOT SHOW THE CHECKMARK FOR THE REGISTRATION CONFIRMED, 6 OUT OF 7 FIDUCIALS WERE RECOGNIZED BY THE SYSTEM, ALTHOUGH THE ENTIRE ICT WAS IN THE SCAN. LANDMARK CHECK SEEMED FINE. PLACED FOUR SCREWS (L5L-L5R-S1L AND S1R). POSTOP SCAN REVEALED THAT ALL SCREWS WERE TOO DEEP AND L5-L WAS LATERAL COMPARED TO THE PLANNING. L5-L SCREW WAS REPLACED WITH STEALTH AND THE OTHER SCREWS WERE BACKED OUT A LITTLE. NOTHING SUGGESTED THAT THE SYSTEM CONSIDERED THE PATIENT TO BE POSITIONED LOWER, ALTHOUGH THE EE WAS ALMOST TOUCHING THE SCAN FOR EACH TRAJECTORY ON A MEDIUM SIZED PATIENT. DURING SCREW PLACEMENT, THE ARM COULD NOT BE MOVED AWAY FROM THE TRAJECTORY AFTER DESELECTING THE SCREW AND PRESSING THE FOOT SWITCH. THE ONLY WAY TO MOVE THE ARM AWAY WAS BY USING THE BRACELET.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IMPLANTATION; EGPS WAS MOVED INTO POSITION. DR. (B)(6) COMPLETED LANDMARK CHECKS BY SELECTING THE DESIRED LEVEL AND USING THE CHICKEN FOOT TO PROBE THE SPS AND LAMINAS. WE THEN ADVISED DR. (B)(6) TO USE THE FLUORO IMAGE SELECTOR TO VISUALIZE THE FLUORO IMAGES RATHER THAN THE CT. THE FLUORO IMAGES SHOWED THE CORRECT POSITION FOR THE SCREW FOR L3 SO DR. (B)(6) PROCEEDED WITH IMPLANTATION. SCREW PREPARATION CONSISTED OF A 4.5MM HS DRILL, TIPPED QUARTEX DRILL, FOLLOWED BY THE SCREW. BETWEEN EACH INSTRUMENT DR. (B)(6) USED A BALL TIP PROBE TO CHECK TO MAKE SURE THE SCREW NEVER BREACHED THE PEDICLE AND STEMMED THE SCREW ONCE PLACED. AFTER REMOVING THE EGPS WE NOTICED THAT S1 SCREWS WERE PLACED TOO FAR SUPERIOR IN LAT X-RAY AIMING TOWARDS THE DISC SPACE SO DR. (B)(6) IMMEDIATELY REMOVED THE SCREWS. HE THEN MOVED THE SCREWS DOWN INFERIORLY ON THE PLAN AND CHECKED THEIR POSITION ON FLUORO VIEW. HE THEN RE-IMPLANTED THE S1 SCREWS INTO THE CORRECT DESIRED POSITIONS WITHOUT RE-REGISTERING. ALL SCREWS WERE CONFIRMED ACCURATE WITH FLUOROSCOPY AND NEUROMONITORING. AFTER THE CASE AND PRIOR TO THE SECOND CASE, I URGED HIM TO WAIT A FEW SECONDS AFTER THE MOVEMENT METER DROPS TO 0% PRIOR TO TAKING SH

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: PRE OP CASE. PEDIATRIC SCOLI. 13 Y.O. FAMALE. T5-L5 PEDICLE SCREWS MIS. 2021R1P1. PHILIPS PULSERA C-ARM 12 INCH. DR.(B)(6) WORKFLOW FOR THIS KIND OF CASES ITS TO START FROM TORACIC SCREWS CLAMPING DRB ON T11 AND SM T10 CAMERA TO THE FEET AND ROBOT COMING FROM THE HEAD OF THE PATIENT. FOR LOWER LEVELS HE LIKES TO INVERT POSITION TO DRB AND SM IN ORTHER TO USE THE SAME SPINOUS PROCESSES AND NOT HAVING TO MAKE OTHER INCISIONS TO PEDIATRIC PATIENTS. WE TOOK APS AND LATERALS SHOTS AS USUAL. THE MERGE WAS SHOWING SHIFT ON LATERAL IMAGES FOR T5 AND T10. WE CHOOSE A NEW AP FOR T5 AND IT MERGED WELL. WE DECIDED TO DO NOT TAKE NEW SHOTS FOR T10, THE IDEA WAS TO MERGE T10 WITH THE SECOND SECTION OF THE COLUMN T10-L4/L5. WE STARTED PLACE SCREWS FROM T5 BOTH SIDES. ALL GOOD SINCE T8. WHEN WE INSERTED HIGH SPEED DRILL IN THE EE WE NOTICE THAT NAVIGATION WAS NOT PRECISE. SO WE MOVED AWAY EE AND WE PERFORMED NAVIGATION CHECK BY USING NAVIGATED INSTRUMENT. WE NOTICED AN INCH OF DIFFERENCE BETWEEN WHERE WE WERE WITH THE INSTRUMENT FROM WHAT WE SAW ON THE SCREEN. THE DISCREPANCY SEEMED TO BE ON THE DEPTH. THE INSTRUMENT IN CONTACT WITH THE PATIENT'S ANATOMY WAS ON THE SCREEN ABOUT A CENTIMETER AWAY.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE MATCHING WAS DONE AND WE STARTED TO APPROACH WITH THE ROBOT. THE SCREWS WERE ONLY NECESSARY ON THE RIGHT SIDE, SO WE GOT ALL THREE RIGHT SCREWS GREEN FRAME AND STABILIZED THE ROBOT IN THAT POSITION. SELECTED A SCREW AND PRESSED THE FOOTPADDLE, WITH THE IMMEDIATELY GOT THE MESSAGE TRAJECTORY OUT OF RANGE. IT STAYED LIKE THAT AFTER SOFTWARE RESET, SWITCH TO CRANIAL AND BACK AND TO 3 HARD SHUTDOWNS INCLUDING PULLING OUT THE ELECTRIC CORD. NOTHING CHANGED THE TRAJECTORY OUT OF RANGE MESSAGE.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: L4-5 INTRA-OP CASE. REGISTRATION NORMAL/NO ERRORS/NO SHIFTS. SCREW PLACEMENT: L4-R PLACED, SELECTED L5-R, PRESSED FOOT PEDAL, EE CAME OFF L4-R LIKE NORMAL. MOVED EE OUT OF WAY WITH RING. ADJUSTED L5-R PLAN, BACK TO NAVIGATE, PRESSED FOOT PEDAL, ARM FLOATED TO THE SIDE. THEN ARM LOCKED UP/WOULD NOT MOVE VIA BUTTONS, FOOT PEDAL, OR RING. ARM WOULD NOT MOVE, RE-HOME, OR RE-CALIBRATE LOADCELL AFTER MULTIPLE HARD SHUTDOWNS AND SOFTWARE RESETS.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON 3/27 A CASE WITH DR.(B)(6). 4 SCREWS PLACED ROBOTICALLY USING CREO MIS AND INTRA-OP CT SCAN WITH EXCELISIUS360. CT SCAN AND ROBOTIC PLACEMENT WENT WELL. AFTER SCREWS IN, I BELIEVE LL5 SCREW WAS PLACED TOO ANTERIOR TO PLAN. NO ADVERSE EFFECTS TO PT, SCREW WAS BACKED OFF A FEW MM. SURGEON DOES WANT TO USE ROBOT UNTIL ISSUE IS RESOLVED/ FIGURE OUT WHAT WENT WRONG. CASE LONGS HAVE BEEN SUBMITTED TO IN TEAM.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THIS CASE WAS PERC SCREWS AT T11-L3, SKIPPED L1. WE USED E3D AS INTRA OP SCAN WITH AUTOMATIC REGISTRATION. T11 - T12 SCREWS WERE PLACED FIRST, UPON THESE SCREWS BEING PLACED IT WAS NOTICED THERE WAS SIGNIFICANT DEFLECTION, IT WAS THEN DETERMINED TO UTILIZE THE TAP FOR THE REMAINING SCREWS, T12 R (THE LAST THORACIC SCREW) - L3 (WHICH WERE ALL PLACED TO PLAN). WE DECIDED TO SPIN AND WE CONNECTED TO ROBOT INCASE ANY SCREWS NEEDED REDONE. UPON SPINNING AFTER ALL SCREWS WERE PLACED, 2 SCREWS WERE MISSED T12 L (MEDIAL) AND T11 R (LATERAL). WE USED THE NEW REGISTRATION TO REPLACE BOTH SCREWS, T12 L WAS REPLACED EXACTLY TO PLAN, BUT T11 R WAS OFF PLAN (MEDIAL) AFTER TAKING A FINAL SPIN TO CONFIRM FINAL PLACEMENT. PLEASE ADVISE AS TO WHY SCREWS WERE MISSED.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AFTER REPOSITIONING THE ROBOT INTO THE FIELD AND MOVING TO S1L A DRILL WAS PLACED DOWN THE EE. THE OFFSET WAS FULLY RED AS THE INSTRUMENT PASSED DOWN THE EE. DRILL WAS REMOVED, AND EE RESETTLED TO GREEN BORDERS AGAIN. AGAIN, THE DRILL WAS PLACED THROUGH THE EE, AND OFFSET WAS FULLY RED. THE ARRAY ON THE DRILL WAS MOVED, SURGEON ADJUSTED THE DRILL BATTERY TO REDISTRIBUTE THE WEIGHT, AND IT STAYED RED. SURGEON REQUESTED THE ROBOT BE PULLED FROM THE FIELD, AND THE CASE WAS FINISHED WITH STEALTH NAVIGATION.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: CASE WAS PERFORMED AS AN OPEN, FOR L2-S2 CONSTRUCT. DUE TO THE INABILITY TO GET THE BOTTOM HALF OF THE PELVIS IN ONE INTRA-OP SPIN USING O-ARM, CASE WAS EXECUTED USING 2 SPINS/CASES/MERGES, BUT SAME DRB/SURVEILLANCE MARKER PLACEMENT FOR EACH CASE. PATIENT WAS POSITIONED PRONE THROUGHOUT THE ENTIRETY OF THE CASE. DRB WAS PLACED IN PATIENT RIDE SIDE PSIS AND SURVEILLANCE MARKER WAS PLACED IN PATIENT'S LEFT SIDE PSIS. WE PROCEEDED WITH OUR TWO PINS FOR OUR PREOP WORKFLOW. SCREWS WERE PLANNED FOR OUR FIRST CASE AS L2-S1 AND WERE CHECKED/CONFIRMED BY DR. (B)(6). SCREWS WERE PLANNED FOR OUR SECOND CASE AS L5-S2 AND WERE CHECKED/CONFIRMED BY DR. (B)(6), AGAIN. WE INITIALLY MERGED OUR FIRST CASE AND EXECUTED PUTTING SCREWS IN AT LEVELS L2-S1. THESE SCREWS ALL WENT IN GREAT AND LOOKED SPOT ON OUR FINAL X-RAYS. WE THEN PROCEEDED WITH OUR SECOND CASE MERGING LEVELS L5-S2. THIS CASE WAS ONLY USED TO PUT IN S2AI SCREWS. WE WERE ABLE TO GET A SUCCESSFUL MERGE AND THEN PROCEEDED WITH PUTTING IN S2AI SCREWS. DR. (B)(6) WAS WORKING FROM PATIENT'S RIGHT SIDE, SO WAS ABLE TO PUT PATIENT'S LEFT SIDED SCREW IN UTILIZING HIGH SPEED BURR, MCS DRILL, TAP, SCREW ON POWER TECHNIQUE WITH EASE. WE THEN PROCEE

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE ROBOT IS HAVING SOME PROBLEMS. THE SOFTWARE HAS BEEN EXTREMELY SLOW, VARIOUS GLITCHES WHILE OPERATING, MERGING HAS GOTTEN INCREASINGLY MORE DIFFICULT, AND SCORES KEEP GOING DOWN WITH BOTH PREOP CT AND O-ARM SPINS. THE LAST TWO CASES WE'VE HAD SCREWS PLACED IN AREAS NOT PLANNED BUT LUCKILY THE SURGEON DIDN'T FEEL RIGHT SO HE STOPPED AND DID IT BY HAND.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: GPS WAS UNABLE TO LOAD INTRO-OP SPIN TO GENERATE THE STUDY. A SCAN WAS DONE WITH THE O-ARM AND WAS SAVED ON 2 DIFFERENT USB DRIVES, TRYING BOTH USB PORTS ON THE GPS WITH THE SAME RESULT. THE STATUS BAR WAS STALLING/FREEZING AT ABOUT 85%. WE HAD TO HOLD DOWN THE POWER BUTTON TO POWER CYCLE THE GPS TO GET IT UNFROZEN FROM THAT LOADING SCREEN. WE PERFORMED A 2ND SCAN WITH THE O-ARM TO MAKE SURE THE ISSUE WAS NOT WITH THE FIRST STUDY WITH THE SAME RESULTS USING THE SAME METHODS. THE GPS AT ONE POINT WOULD NOT POWER DOWN BY HOLDING DOWN THE POWER BUTTON BUT EVENTUALLY DID. DURING THE REBOOT OF THE GPS, THE SCREEN REMAINED DARK WITH RED STATUS LIGHT ON 2 DIFFERENT OCCASIONS AS WELL. DR. (B)(6) WANTS A TECHNICIAN TO COME LOOK AT THIS UNIT AS SOON AS POSSIBLE. HE CANCELED THE CASE AND HAD THE PATIENT WOKEN UP FROM ANESTHESIA DUE TO THIS MALFUNCTION.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: SCREWS PLANNED ON EGPS UNIT WERE NOT EXECUTED TO PLAN IN PATIENT - SCREWS SHIFTED LATERALLY. COULD YOU PLEASE EVALUATE THE LOGS AS WE HAD SIGNIFICANT SHIFT ON SCREW VS PLAN ON TIS PATIENT.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DR. (B)(6) DID A REVISION L1-S1 TODAY AT THE SURGERY CENTER USING E3D AND EGPS. THE PT WAS DRAPED AND THE DRB WAS PLACED IN THE RIGHT PSIS, AND WAS MARKED USING A SKIN MARKER. WE PROCEEDED WITH AN E3D SPIN AND TRANSFERRED THE INTRA-OP CT TO EGPS. THE PT WAS THEN EXPOSED, INSTRUMENTATION WAS REMOVED AND WE CONTINUED WITH THE EGPS SYSTEM PUTTING IN SCREWS. WE GOT TO L5 AND THE DRB WAS BUMPED AND ROTATED, AT WHICH POINT WE ABORTED TO ROBOT AND FREE HANDED SCREWS AT S1. X-RAYS WERE TAKEN OF THE SCREWS PLACED, RIGHT L1 AND L2 WERE LATERAL, AND THE SURGEON REPLACED THEM FREE HAND. LEFT L1 WAS DETERMINED TO BE TOO MEDIAL AND WAS ALSO REPLACED. THE REMAINING SCREWS WERE CHECKED VIA FLUORO SHOTS AND WERE CONFIRMED TO BE PLACED ADEQUATELY.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DR. (B)(6) PLANNED TO PLACE SCREWS AT L3-4 BILATERALLY, HE DID A MIDLINE INCISION AND PERFORMED LAMINECTOMY AT L3, AND DECOMPRESSION AT BOTH LEVELS. AFTER DECOMPRESSION COMPLETED AND SURGEON HAPPY WITH IT, WE PLACED SP CLAMP ON L5 SPINOUS PROCESS. DRB WAS PLACED AND WE WENT TO TAKE SHOTS. WE SUCCESSFUL MERGED L3 AND L4. ALL 4 SCREWS WERE PLACED USING WORKFLOW HIGH SPEED DRILL, 3.5 DRILL THEN SCREW PLACED. WE TOOK A SHOTS TO CONFIRM SCREW PLACEMENT, ON AP WE SAW OUR FIRST SCREW LEFT L3 WAS BREACHED LATERALLY. THE OTHER 3 SCREWS WERE PLACED TO PLAN. WE DIDN'T NOTICE INSTRUMENTS GOING LATERALLY WHEN PREPARING HOLE FOR SCREW. SCREW WAS REMOVED AND WE MADE SURGEON NAVIGATION WAS STILL ACCURATE. WE WENT TO PLACE SCREW AGAIN, USING HIGH SPEED BURR, AND 3.5 DRILL, PLACED SCREW. AGAIN, IT WAS BREACHED LATERALLY. WE REMOVED BOTH LEFT SIDE SCREWS AND JUST PLACED ROD AND LOCKING NUTS ON RIGHT SIDE.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING THE MERGE OF OUR CASE, THE SI JOINT LEVELS WOULD NOT POPULATE AFTER THE MERGE. CREO SCREWS WERE PLANNED AT 5-1 AND ADJUSTED TO 4-1 DURING OTHER ATTEMPTS. SI-LOK WAS PLANNED BILATERALLY. ALL NEW IMAGES WERE TRIED FIRST. THEN, A NEW CASE WITH NEW IMAGES WAS TRIED AS WELL. SOFTWARE RESET, HARD SHUT DOWN, CRANIAL AND BACK WERE TRIED AS WELL. THIS ACCOUNT HAS BEEN REGULARLY DOING SI-LOK CASES WITH NO ISSUES. THE MERGE WAS SUCCESSFUL AT L4-S1. MULTIPLE CSR'S WERE CALLED ALONG WITH OTHER MEMBERS OF THE TEAM UNABLE TO DISCERN THE ISSUE. THE CASE WAS UNABLE TO BE COMPLETED AND THE OPERATION WAS DONE UNDER FLUORO.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: CASE FLOW: PATIENT WAS PREPPED AND POSITIONED PER STANDARD MEANS AND SCOUT SHOTS OF LUMBAR ANATOMY WAS TAKEN VIA X-RAY AND VERTEBRAL MARKS PLACED ON SKIN. DR. (B)(6) THEN EXPOSED L1 AND L2 PLACING THE SPINOUS PROCESS CLAMPS FOR THE DRB (ON L2) AND ICT/ SURVEILLANCE MARKER (SM) (ON L1). SM WAS REGISTERED AND THE O-ARM BROUGHT INTO POSITION AT TABLE. P/A, LAT, AND A/P SCOUT SHOTS WERE TAKEN TO ENSURE CORRECT LEVELS AND ICT FRAME FIDUCIALS WERE VISUALIZED FOR THE SPIN. SOME ADJUSTMENTS TO THE ICT FRAME AND PIVOT ARM WERE MADE TO ENSURE THAT EVERYTHING WAS ALIGNED. AT THIS TIME THE FIELD CAPTURE SNAPSHOT WAS TAKEN, THE ICT/DRB WERE COVERED WITH BLUE STERILE CLOTH, RESPIRATIONS HELD AND A CT SPIN WAS TAKEN. THE SCAN WAS CHECKED TO ENSURE THE ICT AND FIDUCIALS WERE ALL CAPTURED. THE SCAN WAS EXPORTED VIA USB THUMB DRIVE AND TRANSFERRED SUCCESSFULLY TO THE EXCELSIUS GPS WHERE THE REGISTRATION FIT WAS VERY GOOD. THE O-ARM WAS REMOVED FROM THE TABLE, BLUE CLOTH REMOVED, ICT PIVOT ARM REMOVED FROM CLAMP, SM REMOVED TO SLIDE OFF ICT CLAMP AND REPLACED. SKIN LANDMARK CHECKS WERE DONE AND SM WAS RE-REGISTERED. SINCE L1 SPINOUS PROCESS WAS VISIBLE IN THE SCAN AND DIRECT ACCESS WAS POSSIBLE VIA T

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: NEXT, AS WE BEGAN NAVIGATING, WE POSITIONED THE ROBOT NEAR THE PATIENT, AND GREEN BOXES APPEARED FOR OUR DESIRED LEVELS SIGNALING THAT TRAJECTORY WAS WITHIN RANGE. STABILIZERS WERE DEPLOYED, A SINGLE LEVEL WAS SELECTED, BUT AS THE SURGEON PRESSED THE FOOT PEDAL, A "TRAJECTORY WAS NOT WITHIN RANGE" WARNING APPEARED. WE ATTEMPTED TO REPOSITION THE ROBOT MULTIPLE TIMES, AND EACH TIME THE WARNING APPEARED. THIS PROHIBITED US FROM PROCEEDING.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MISSED S2AI SCREWS BOTH MEDIAL.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MOTION CONTROL. COMMUNICATION FAILED ERROR. THIS KEEPS POPPING UP.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: CASE INFO: DR. (B)(6). L4-S2AI CORTICAL TRAJECTORY OPEN FUSION. 1.1R4 EGPS SOFTWARE. SETUP; DR. (B)(6)' PA, DAMIEN, IMPLANTED THE DRB VIA THE QUATTRO SPIKE INTO THE RIGHT PSIS. (B)(6) THEN IMPLANTED THE SM IN THE LEFT PSIS. EGPS POSITIONED ON THE SAME SIDE AS DAMIEN AND THE C-ARM OPPOSITE THE OR DOOR. CAMERA WAS POSITIONED AT THE FOOT OF THE BED. EXTRA MONITOR FROM SSI USED FOR DR. (B)(6) DURING REGISTRATION THEN FOR (B)(6) FOR SCREW PLACEMENT. (B)(6) THEN VERIFIED SURVEILLANCE. REGISTRATION; THE REGISTRATION TOOK 5 MINUTES. AFTER A SUCCESSFUL MERGE, (B)(6) COMPLETED A LANDMARK CHECK. IMPLANTATION; (B)(6) IMPLANTED EACH SCREW USING; FIRST, THE 4.5 HS DRILL/3.5 TIPPED DRILL, FOLLOWED BY THE SCREW- EVENTUALLY SKIPPING THE 4.5MM HS DRILL. SCREW PLACEMENT FROM L4-S1 TOOK 10 MINUTES. FOR S2AI IT TOOK 30 MINUTES. DR. (B)(6) USED THE TIPPED 5.0/6.0MM CREO MCS DRILL WITH THE 60MM HARD STOP THEN USED A TAP TO GET ACROSS THE JOINT. S2AIL IMPLANTATION WAS SUCCESSFUL BUT S2AIR BREACHED ANTERIORLY. ***WE BELIEVE THAT THE STARTING POSITION FOR S2AIR BEING MORE INFERIOR (PLANNED BELOW 3X SI-BONE SCREWS) THE SI JOINT WAS FURTHER THAN THE HARD STOP PREVENTING THE TIPPED DRILL FROM SUCCESSFULLY CROS

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE HOSPITAL JUST PURCHASED TWO NEW CT MACHINES AND HAS A SLIGHT TURNOVER OF CT TECH STAFF. THE FIRST SCAN LOADED ONTO THE ROBOT WITH A YELLOW WARNING. I CLICKED THROUGH IT NOT THINKING TWICE BECAUSE THE SCAN POPULATED ON THE IMAGE LOCAL PAGE/ALLOWED ME TO PROCEED TO PLAN. WHEN REGISTERING THE X-RAYS TO THE SCAN (PREP CUT WORKFLOW), THE ERROR "FLUORO-CT IMAGE REGISTRATION FAILED" IN YELLOW POPULATED THE SCREEN. I TRIED RESETTING THE SOFTWARE, RESTARTING THE ROBOT, EVEN CHANGING THE SCAN TO ANOTHER ONE TITLED "THINS" (INSTEAD OF THE PRESET "GLOBUS 1MM BY 1MM") AND RE-REGISTERING. NOTHING WORKED, AND THE SURGEON ENDED UP BAILING ON THE ROBOT.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: POWER NOT GETTING TO ROBOT. APPEARS TO BE A FUSE ISSUE.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DR. (B)(6) FIRST DBS PROCEDURE WITH EGPS AND E3D HAD TO BE ABORTED DUE TO MISSED TRAJECTORIES, THAT IS BELIEVED TO BE DUE TO MERGE ISSUES WITH THE PRE-OP T1 MRI. THE PATIENT WAS ATTACHED TO THE PSS WITH A LEKSELL HEAD-FRAME, AND A THE LEKSELL FRA WAS USED FOR REFERENCE. A NON-STERILE INTRAOP REGISTRATION WAS PERFORMED WITH E3D AND LANDMARKS WERE CHECKED SHOWING AN ACCURATE REGISTRATION. THE PATIENT WAS PREPPED AND DRAPED AND INCISION AND BURR-HOLES WERE MADE. THE ROBOT WAS BROUGHT BACK INTO POSITION AND A THIRD LANDMARK VERIFICATION WAS PERFORMED, A TEST TRAJECTORY WAS SET UP AND THE ROBOT SHOWED ACCURATE PLACEMENT. THE ROBOT WAS SENT TO THE LEFT GPI TRAJECTORY AND THE LEAD WAS PLACED. A STERILE EVALUATION SPIN WAS COMPLETED WITH E3D AND SHOWED AN ANTERIOR TO POSTERIOR LEAD PLACEMENT, BISECTING THE INTENDED TRAJECTORY. LANDMARK CHECKS WERE PERFORMED AGAIN SHOWING A SLIGHTLY DEEP INSTRUMENT IN THE CT SCAN. IT WAS ALSO NOTICED THAT THE ALPHA OMEGA XY BASE STAGE WAS LOOSE AND ROCKING BACK AND FORTH. IT WAS DECIDED TO RE-REGISTER THE PATIENT WHICH WAS SUCCESSFULLY PERFORMED. LANDMARK CHECKS SHOWED AN ACCURATE REGISTRATION. THE ROBOT WAS SENT BACK TO THE TRAJECTORY AND THE LEAD WAS REPL