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.

Monarch Platform — 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 THE FIRST CASE OF THE DAY THE PHYSICIAN EXPERIENCED JUMPY NAVIGATION DURING THE PROCEDURE. THE CASE WAS ABORTED DUE TO THE NAVIGATION BEING OFF AND THE SCOPE COULD NOT PHYSICALLY MANEUVER IN THE AIRWAY. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT BECAUSE OF THE SYSTEM ISSUES.

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.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED DURING A MONARCH BRONCHOSCOPY PROCEDURE, A RECURRENT ELECTROMAGNETIC (EM) NAVIGATION FAULT OCCURRED AT SYSTEM REGISTRATION. THE PHYSICIAN ELECTED TO ABORT THE DIAGNOSTIC PROCEDURE. NO CLINICAL CONSEQUENCES TO THE PATIENT WERE REPORTED DUE TO THIS EVENT.

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.

Monarch Platform — 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 DIAGNOSTIC PROCEDURE USING THE MONARCH BRONCHOSCOPY SYSTEM, THE PHYSICIAN DECIDED TO ABORT THE DIAGNOSTIC PROCEDURE DUE TO NAVIGATIONAL DIFFICULTY. THE PATIENT WAS REPORTED TO HAVE A LOT OF MUCUS. THE PHYSICIAN DECIDED TO ABORT THE DIAGNOSTIC PROCEDURE. THERE WAS NO REPORTED DEVICE MALFUNCTION ASSOCIATED WITH THE ADVERSE EVENT. NO MEDICAL OR SURGICAL INTERVENTION REPORTED. NO HOSPITALIZATION REQUIRED.

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

Monarch Platform — 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 SUCCESSFUL DIAGNOSTIC PROCEDURE USING THE MONARCH BRONCHOSCOPY SYSTEM, THE PATIENT REPORTED HAVING HYPOXIA WHICH IS A PRE-EXISTING CONDITION THAT IS ATTRIBUTED TO MEDICAL HISTORY OF COPD. THE PATIENT WAS HOSPITALIZED AND SUPPLEMENTAL OXYGEN (3L 02) WAS GIVEN AND RELEASED THE FOLLOWING DAY. NO ISSUES WERE REPORTED REGARDING THE MONARCH SYSTEM.

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.

Monarch Platform — 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 MONARCH BRONCHOSCOPY THE PHYSICIAN REMOVED A FOREIGN OBJECT WHILE WITHDRAWING THE SPECIMEN TISSUE FROM THE SPECIMEN.

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.

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: PT (PATIENT) HAD HARDWARE PLACED (B)(6) 2021 AND ON FOLLOW UP X-RAY, CT (COMPUTED TOMOGRAPHY) AND MRI (MAGNETIC RESONANCE IMAGING) REVEALED THE BACKING OUT OF THE SCREWS AT C5 LEVEL AS WELL AS A BROKEN LOCKING MECHANISM. (B)(6) 2023: PT HAD SURGERY: REVISION ANTERIOR CERVICAL APPROACH REMOVAL OF OLD HARDWARE REVISION OF C4-5 FUSION RE INSTRUMENTATION FROM C3 TO C5 THE CAGES USED (B)(6) 2021 WERE: 1. IMPLANT-INTRBDY CERV POR CASCADIA 13X16X7 ¿ SNONE 2. IMPLANT-INTRBDY CERV POR CASCADIA 13X16X7 ¿ SNONE (LOOKS LIKE THEY USED THE SAME SIZE CAGES FOR BOTH LEVELS) THE PLATE USED WAS: PLATE 2 LEVEL OZARK VIEW 40MM ¿ SNONE THE SCREWS USED WERE: SCREW VARI SELF-START OZARK 4X16MM ¿ SNONE (THERE WERE MOST LIKELY 6 SCREWS, LOOKS LIKE ALL WERE SAME SIZE) COMPANY AT THE TIME OF INITIAL SURGERY IN 2021 IS K2M- COMPANY NAME CHANGED TO STRYKER. REFERENCE REPORTS: MW5120510 AND MW5120512.

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: PT (PATIENT) HAD HARDWARE PLACED (B)(6) 2021 AND ON FOLLOW UP X-RAY, CT (COMPUTED TOMOGRAPHY) AND MRI (MAGNETIC RESONANCE IMAGING) REVEALED THE BACKING OUT OF THE SCREWS AT C5 LEVEL AS WELL AS A BROKEN LOCKING MECHANISM. (B)(6) 2023: PT HAD SURGERY: REVISION ANTERIOR CERVICAL APPROACH REMOVAL OF OLD HARDWARE REVISION OF C4-5 FUSION RE INSTRUMENTATION FROM C3 TO C5 THE CAGES USED (B)(6) 2021 WERE: 1. IMPLANT-INTRBDY CERV POR CASCADIA 13X16X7 ¿ SNONE 2. IMPLNT-INTRBDY CERV POR CASCADIA 13X16X7 ¿ SNONE (LOOKS LIKE THEY USED THE SAME SIZE CAGES FOR BOTH LEVELS) THE PLATE USED WAS: PLATE 2 LEVEL OZARK VIEW 40MM ¿ SNONE THE SCREWS USED WERE: SCREW VARI SELF-START OZARK 4X16MM ¿ SNONE (THERE WERE MOST LIKELY 6 SCREWS, LOOKS LIKE ALL WERE SAME SIZE) COMPANY AT THE TIME OF INITIAL SURGERY IN 2021 IS K2M- COMPANY NAME CHANGED TO STRYKER. REFERENCE REPORTS: MW5120511 AND MW5120512.

Monarch Platform — 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 DIAGNOSTIC PROCEDURE USING THE MONARCH BRONCHOSCOPY SYSTEM, BLEEDING WAS NOTED. THE PHYSICIAN CONVERTED THE PROCEDURE TO A TRADITIONAL BRONCHOSCOPY AND A BALLOON WAS USED TO PROVIDE TAMPONADE. PER THE PHYSICIAN, THE PRIMARY CAUSE OF THE PATIENT BLEED WAS DUE TO THE PATIENT¿S FRAGILE AIRWAYS AND PRE-EXISTING CONDITION. THERE WAS NO REPORTED DEVICE MALFUNCTION ASSOCIATED WITH THE ADVERSE EVENT. NO HOSPITALIZATION REQUIRED.

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: PT (PATIENT) HAD HARDWARE PLACED (B)(6) 2021 AND ON FOLLOW UP X-RAY, CT (COMPUTED TOMOGRAPHY) AND MRI (MAGNETIC RESONANCE IMAGING) REVEALED THE BACKING OUT OF THE SCREWS AT C5 LEVEL AS WELL AS A BROKEN LOCKING MECHANISM. (B)(6) 2023: PT HAD SURGERY: REVISION ANTERIOR CERVICAL APPROACH REMOVAL OF OLD HARDWARE REVISION OF C4-5 FUSION RE INSTRUMENTATION FROM C3 TO C5 THE CAGES USED (B)(6) WERE: 1. IMPLANT-INTRBDY CERV POR CASCADIA 13X16X7 ¿ SNONE 2. IMPLANT-INTRBDY CERV POR CASCADIA 13X16X7 ¿ SNONE (LOOKS LIKE THEY USED THE SAME SIZE CAGES FOR BOTH LEVELS) THE PLATE USED WAS: PLATE 2 LEVEL OZARK VIEW 40MM ¿ SNONE THE SCREWS USED WERE: SCREW VARI SELF-START OZARK 4X16MM ¿ SNONE (THERE WERE MOST LIKELY 6 SCREWS, LOOKS LIKE ALL WERE SAME SIZE) COMPANY AT THE TIME OF INITIAL SURGERY IN 2021 IS K2M- COMPANY NAME CHANGED TO STRYKER. REFERENCE REPORTS: MW5120510 AND MW5120511.

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.

Monarch Platform — 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 RECURRENT FAULT STATE OCCURRED DURING THE SETUP OF THE MONARCH BRONCHOSCOPY SYSTEM, PREVENTING THE USE OF THE SYSTEM. THE DIAGNOSTIC PROCEDURE WAS ABORTED. THE PATIENT HAD ALREADY BEEN ANESTHETIZED. NO CLINICAL CONSEQUENCES TO THE PATIENT WERE REPORTED DUE TO THIS EVENT.

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.

Monarch Platform — 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 DIAGNOSTIC MONARCH BRONCHOSCOPY PROCEDURE, BLEEDING WAS DETECTED DURING THE BIOPSY, AND THE SYSTEM WAS REMOVED FROM THE PATIENT. THE PHYSICIAN USED A MANUAL SCOPE TO SUCTION BLOOD AND A BLOOD CLOT FROM THE LUNG. THE PROCEDURE WAS ABORTED AND THE PATIENT WAS TRANSFERRED TO THE ICU WHERE A PNEUMOTHORAX WAS DETECTED. THE PATIENT WAS TREATED WITH A CHEST TUBE AND REMAINS IN THE ICU. THERE WAS NO DIFFICULTY EXPERIENCED DURING THE BIOPSY AND THERE WERE NO REPORTED DEVICE ISSUES RELATED TO THIS EVENT.

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.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

Monarch Platform — 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 RECURRENT FAULT STATE OCCURRED DURING INITIAL SYSTEM REGISTRATION OF THE MONARCH BRONCHOSCOPY SYSTEM, PREVENTING THE USE OF THE SYSTEM. THE DIAGNOSTIC PROCEDURE WAS ABORTED. THE PATIENT HAD ALREADY BEEN ANESTHETIZED. NO CLINICAL CONSEQUENCES TO THE PATIENT WERE REPORTED DUE TO THIS EVENT.

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.

Monarch Platform — 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 SUCCESSFUL DIAGNOSTIC PROCEDURE USING THE MONARCH BRONCHOSCOPY SYSTEM, A PNEUMOTHORAX WAS NOTED ON THE PATIENT¿S POST PROCEDURAL X-RAYS. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND WAS ASYMPTOMATIC. NO ADDITIONAL INTERVENTION WAS NECESSARY, AND THE PATIENT WAS DISCHARGED ONE (1) DAY LATER. THERE WAS NO REPORTED DEVICE MALFUNCTION ASSOCIATED WITH THE ADVERSE EVENT.

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