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

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.