Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE FOLLOWING INFORMATION WAS PROVIDED: I&D OF RIGHT KNEE WITH MEDIAL UNI POLY SWAP OUT DUE TO INFECTION.

Versius — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE REPORTER ALLEGED THAT DURING A LEFT INFERIOR LOBECTOMY PROCEDURE ON (B)(6) 2026, WHILST USING A BIPOLAR MARYLAND GRASPER PART OF THE LUNG'S TISSUE GOT STUCK IN THE JOINT AND WAS UNABLE TO REMOVE THE TISSUE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. CMR SURGICAL LTD DOES NOT CONSIDER THIS REPORT AND CONTENT TO BE AN ADMISSION THAT ITS PRODUCT IS DEFECTIVE OR THAT IT HAS CAUSED A DEATH OR SERIOUS INJURIES.

VELYS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING LEFT TKA ROBOTICALLY ASSISTED VELYS CASE- VELYS SAW HAND PIECE BROKE. NO HARM TO PATIENT.

Versius — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE REPORTER ALLEGED THAT DURING A SACROCOLPOPEXY PROCEDURE ON (B)(6) 2026 THE SURGEON OBSERVED THAT THERE WAS A PIECE OF COLON TISSUE STUCK IN THE CADIERE GRASPER. IT WAS NOT POSSIBLE TO PULL IT OUT AND THE TISSUE HAD TO BE CUT LOOSE. BESIDE THIS CUTTING THERE WAS NO HARM TO THE PATIENT AND THE ISSUE DID NOT OCCUR AGAIN. THE PATIENT HAS RECOVERED WELL FROM SURGERY AND HAS BEEN DISCHARGED FROM HOSPITAL WITH NO COMPLICATIONS. AT THE TIME OF THIS REPORT, NO FURTHER INFORMATION HAS BEEN PROVIDED. CMR SURGICAL LTD DOES NOT CONSIDER THIS REPORT AND CONTENT TO BE AN ADMISSION THAT ITS PRODUCT IS DEFECTIVE OR THAT IT HAS CAUSED A DEATH OR SERIOUS INJURY

Versius — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS ALLEGED THAT THE SURGEON CONSOLE WENT INTO A MEDIUM PRIORITY ALARM DURING SURGERY AND THE RIGHT HAND CONTROLLER ARM BECAME STILL. THE SURGEON CONSOLE COULD NOT BE RECOVERED AND THE PROCEDURE WAS CONVERTED. IT IS ALLEGED BY THE REPORTER (DISTRIBUTOR) THAT THE PROCEDURE WAS CONVERTED TO OPEN APPROACH DUE TO THE FOLLOWING PATIENT CONDITIONS: HIGH BLOOD PRESSURE AND BMI OF OVER 30 WITH A LOT OF ABDOMINAL FAT. A DELAY OF APPROXIMATELY 20 MINUTES WAS ALLEGED IN RELATION TO THIS EVENT. NO PATIENT HARM WAS REPORTED IN RELATION TO THIS EVENT. PHOTOS WERE PROVIDED BY THE REPORTER (DISTRIBUTOR) TO SHOW THE MALFUNCTIONING PART. THE MALFUNCTIONING PART WAS REPLACED BY THE DISTRIBUTOR. AT THE TIME OF THIS REPORT, NO FURTHER INFORMATION HAS BEEN PROVIDED.

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE FOLLOWING INFORMATION WAS PROVIDED: I&D OF A LM PKA WITH AN MCK TIBIAL INSERT EXCHANGE DUE TO INFECTION.

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 AN EXCELSIUS GPS SURGERY THERE WAS 4 SCREW CREO MIS BACKUP OF ALIF. THE SM ON RIGHT PSIS DRB ON LEFT PSIS, ICT PLACE ON DRB LP QUATRO SPIKE. THE INTRA OP SPIN WITH O-ARM AND FILES TRANSFERER TO EGPS VIA USB. ALL 4 SCREWS PLANNED BY SURGEON. THE ICT WAS REMOVED AND SM VERIFIED. THE POSTOP SPIN SHOWED 4 SCREWS HAD SHIFTED OF PLAN BY APPROX 2-3MM LATERAL. NO IOM ISSUES. THE SURGEON DECIDED TO REPOSITION THE L5 SCREWS BY HAND.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT WHILE USING THE EXCELSUS GPS SYSTEM, THE SCREW MISSED TARGET AND APPEARED TOO HIGH IN PEDICLE.THEY BELIEVE THE TRAJECTORY WAS SLICED BUT NEED AN ACCURACY CHECK REGARDLESS. THEY REPLACED SCREW WITH NEW PLAN.

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 AN EXCELSIUS GPS SURGERY, THE SURGEON DECIDED TO ABORT A EXCELSIUS GPS SI LOK SURGERY ON (B)(6) 2026. HE WAS NOT CONFIDENT WITH THE ACCURACY AND SAFETY CHECKS. THE ENTIRE SURGERY WAS ABORTED AND THE PATIENT WAS ALREADY UNDER ANESTHESIA.

Ion Endoluminal System — 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 AN ION TRANSBRONCHIAL LUNG BIOPSY PROCEDURE, THE PATIENT DEVELOPED A PNEUMOTHORAX REQUIRING PLACEMENT OF A CHEST TUBE AND HOSPITALIZATION. THE TARGETED LESION WAS A LEFT UPPER LOBE INFERIOR NODULE ABUTTING THE MOST INFERIOR PART OF THE LINGULA BEHIND THE HEART. PER THE PHYSICIAN, THERE WERE SUBOPTIMAL ANGLES AND THE DEPTH PERCEPTION WAS NOT GOOD. FINE NEEDLE ASPIRATIONS (FNA) PASSES AND FORCEPS WERE USED. THE PHYSICIAN REPORTED THAT THEY INSERTED THE FORCEPS FURTHER THAN INTENDED AND LIKELY CAUSED THE PNEUMOTHORAX. A LARGE PNEUMOTHORAX WAS IDENTIFIED DURING THE ION PROCEDURE; THEREFORE, A 14 FRENCH CHEST TUBE WAS PLACED AND THE PROCEDURE WAS ABORTED. THE PATIENT WAS HOSPITALIZED 4 DAYS THEN DISCHARGED HOME IN STABLE CONDITION. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF AN ION SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. THE DIAGNOSIS WAS MAC-NTM (MYCOBACTERIUM AVIUM COMPLEX NONTUBERCULOUS MYCOBACTERIA).

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 REVISION CASE WITH THE SURGEON WE HAD A SCREW PLACED LATERALLY OF THE INTENDED PLANNED SCREW, THE SCREW THAT WAS PLACED LATERALLY WAS THE LEFT L3 SCREW. WE ALSO HAD SOME DIFFICULTY WITH MOTION ON THE MERGE, WHICH WAS SURPRISING BECAUSE THE PATIENT HAD PREVIOUSLY IMPLANTED HARDWARE WHICH USUALLY MAKES THE PROCESS EASIER. THE LATERALLY PLACED SCREW WAS BACKED OUT AND RE-DIRECTED MANUALLY WITHOUT THE ROBOT. NONE OF THIS CAUSED ANY ISSUES WITH THE PATIENT OR PROCEDURE. THE SURGEON HAS REQUESTED THAT THE CALIBRATION OF THE ROBOT BE CHECKED.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT WHILE USING THE EXCELSIUS GPS SYSTEM, A SCREW WAS MISPLACED DURING A T11-L3 PERCFUSION CASE TODAY. THE SCREW WAS REMOVED, AND WE DID THE REST UNDER FLUORO WITHOUT THE ROBOT. EVERY INSTRUMENT HE PUT DOWN THE END EFFECTOR WAS SUPER OFF EVEN THE ANATOMY CHECKS WERE ACCURATE. IT COULD'VE BEEN A SCAN ISSUE WE DON'T KNOW.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AN 82-YEAR-OLD FEMALE UNDERWENT PLANNED THORACIC PERCUTANEOUS INSTRUMENTATION FOR AN UNSTABLE T5 FRACTURE USING ROBOTIC NAVIGATION. DURING THE PROCEDURE, ROBOTIC REGISTRATION WAS PROLONGED AND TECHNICALLY CHALLENGING. DURING PEDICLE SCREW PLACEMENT, LOSS OF RESISTANCE WITH CSF RETURN WAS NOTED AND INSTRUMENTATION WAS STOPPED. SHORTLY THEREAFTER, NEUROMONITORING SIGNALS WERE LOST, AND THE PATIENT EXPERIENCED A PULSELESS ELECTRICAL ACTIVITY (PEA) ARREST WITH RAPID RETURN OF SPONTANEOUS CIRCULATION FOLLOWING BRIEF RESUSCITATION. POST-EVENT EVALUATION DEMONSTRATED ACUTE MYOCARDIAL DYSFUNCTION WITH PATENT CORONARY ARTERIES AND IMAGING FINDINGS CONCERNING FOR THORACIC SPINAL CORD INJURY RELATED TO A MEDIAL PEDICLE BREACH. THE FOLLOWING DAY, THE SERVICE RECEIVED AN URGENT MANUFACTURER SAFETY NOTICE REGARDING ROBOTIC NAVIGATION SOFTWARE ACCURACY.

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 WHEN DOING AN SI JOINT FUSION WITH OUR SURGEON, OUR MERGE SEEMED TO BE GOOD. HOWEVER, UPON STARTING THE FIRST SCREW, THE HIGHSPEED DRILL WAS NOTICEABLY DEEPER THAN ITS ACTUAL DEPTH. WE TRIED TO FIX IT AND WHEN STANDARD TROUBLE SHOOTING WAS DONE NOTHING CHANGED BUT THE SURGEON WANTED TO PROCEED. THE SCREW PLACED WAS POSTERIOR AND INFERIOR TO THE PLAN. WE DECIDED TO COMPLETELY REMERGE. SIMILAR SHOTS WERE TAKEN AND THE SCREWS WERE PLACED TO PLAN WITH NO DEPTH ISSUES.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT WHILE USING THE EXCELSIUS GPS SYSTEM, PEDICLE SCREWS WERE NOT PLACED AS PLANNED WITH THE E3D INTRAOP EXCELSIUS CASE.

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 THE SURVEILLANCE HAS BEEN UNABLE TO HOLD GREEN STATUS AND DRIFTS TO YELLOW AND RED CONSTANTLY FOR THE LAST SEVERAL WEEKS. TODAY ANOTHER SCREW WAS PLACED LATERAL TO THE PEDAL SIMILAR TO WHAT HAPPENED TWO WEEKS AGO ON THE SAME UNIT EXHIBITING THE SAME PROBLEMS. THIS HAPPENED ONE OTHER TIME A FEW WEEKS EARLIER. THE SURGEON REMOVED THE BREACHED SCREW AND REPLACED USING TRADITIONAL NON-ROBOTIC/NAVIGATED MANNER. THE SURGEON HAS PUT OVER A THOUSAND SCREWS IN WITH THE ROBOT AND THIS IS THE SECOND TIME THIS HAS HAPPENED IN THE LAST TWO WEEKS WITH THE SAME UNIT EXHIBITING THE SAME ISSUE.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT WHILE USING THE E3D TO PRE OP MERGE, NAVIGATION LOOKED CORRECT BUT UPON TAKING X-RAYS, NAVIGATION WAS OFF A SIGNIFICANTLY ANTERIORLY. THE DISC PREP THAT WAS DONE BASED OFF THE GPS NAVIGATION ON THE ROBOT RESULTED IN VIOLATING THE INFERIOR ENDPLATE OF THE SUPERIOR VERTEBRAL BODY, WHICH CAUSE THE SABLE CAGE TO SUBSIDE. ON THE NAVIGATION, THE CAGE LOOKED LIKE IT WAS WELL WITHIN THE DISC SPACE, BUT UNDER X-RAY IT WAS CLEARLY NOT. WE TRIED TO RE-PLACE THE CAGE BUT HAD THE SAME RESULT.

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 IN AN EXCELSIUS GPS SURGERY, IT WAS NOTICED THAT AFTER TAKING X-RAYS IN THE OR FOR THE PRE OP CT WORKFLOW AND DOING THE MERGE, THE PLANNED SCREWS WERE TOTALLY WRONG IN THE X-RAY. WE TOOK THEM OUT TO BE NOT HASSITATED. WHEN WE PLACED THE FIDUCIALS INTO THE LATERAL VIEW VERTEBRA, THE AP ONES WERE COMPLETELY OFF AND NEEDED TO BE PLACED IN THE CENTRE. THEN WE HAD AN ANATOMICAL SHIFT IN LATERAL VIEW. WE COULD NOT CHOOSE ALL THE DIFFERENT VIEWS LIKE STANDARD OR STANDARD OPTIMIZED OR L2 SEED AUTOMATICALLY.

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 AN EXCELSIUS GPS SURGERY THE ROBOT WOULD NOT START. IT TURNED ON, BUT THE SCREEN WAS BLACK. THIS HAPPENED TWICE. THE THIRD TIME IT STARTED WITHOUT ANY PROBLEMS. IT UNDOCKED ITSELF DURING THE OPERATION. WE DOCKED IT MANUALLY AND CONTINUED THE OPERATION. EVERYTHING WENT WELL. HOWEVER, AFTER THE INTRAOPERATIVE CT SCAN, 3 OUT OF 8 SCREWS WERE INCORRECTLY INSERTED. WE CLOSED THE CASE IN THE ROBOT AND STARTED A NEW ONE AS IF IT WERE A NEW OPERATION. WE DID A 3D SCAN AGAIN, PLANNED THE SCREWS AND INSERTED THEM. EVERYTHING WENT WELL AND AFTER THE CONTROL SCAN THE SCREWS WERE ALREADY INSERTED CORRECTLY. THE PATIENT DID NOT SUFFER ANY HARM.

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 L1-L5 OPEN TLIF, USING INTEROP WORKFLOW WITH E3D. WE PLACED L1 LEFT SCREW FIRST. THEN CHECKED ALL SCREWS WITH FLUORO AFTER THEY WERE ALL PLACED AND BOTH L1 SCREWS WERE SHIFTED TO THE LEFT. WE THEN WENT IN TO FIX THEM AND DID ANOTHER SPIN, AND IT WAS STILL OFF. WE ENDED UP PLACING BOTH TOP SCREWS FREEHAND WITHOUT NAVIGATION.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT WHILE USING THE EXCELSIUS GPS SYSTEM ROBOT-PLANNED SCREWS WERE NOT ACCURATE. THE PLAN AND MERGER LOOK FINE. I CAN MAIL OR TRANSFER THE FILE LOG FROM THE ROBOT.

VELYS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT THE SURGEON BELIEVED A DISTAL FEMUR FRACTURE MAY HAVE BEEN CAUSED BY BICORTICAL VELYS ARRAY PINS, WHICH CREATED A STRESS RISER. HE STATED THAT HE PLANNED TO PLACE PINS MORE DISTALLY AND UNICORTICALLY PER VELYS RAS STANDARD PIN PLACEMENT. ONE PATIENT WAS TREATED NONOPERATIVELY. ONE PATIENT WAS TREATED WITH A RETROGRADE NAIL. AS STATED IN THE REPORT, LOT NUMBERS WERE NOT AVAILABLE. PINS WERE DISCARDED AT THE CONCLUSION OF THE SURGERY. THE FRACTURES OCCURRED AT A LATER TIME. THERE WAS NO SIGNIFICANT DELAY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

VELYS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: SURGEON BELIEVES FRACTURE OF A DISTAL FEMUR MAY HAVE BEEN CAUSED BY BICORTICAL VELYS ARRAY PINS CAUSING STRESS RISER. HE MENTIONED THAT HE WOULD PLAN TO PLACE PINS MORE DISTAL AND UNICORTICAL AS PER VELYS RAS STANDARD PIN PLACEMENT. ONE PATIENT TREATED NON OPERATIVELY, ONE PATIENT TREATED WITH RETROGRADE NAIL. NO OTHER INFORMATION CURRENTLY AVAILABLE, NO LOT NUMBERS ARE AVAILABLE. LIST ANY J&J PRODUCTS THAT WERE UTILIZED DURING THE CASE BUT DID NOT CONTRIBUTE TO THE REPORTED EVENT. J&J EQUIPMENT INCLUDED ALL INSTRUMENTS, IMPLANTS AND DISPOSABLE NECESSARY TO COMPLETE A CEMENTLESS ATTUNE PRIMARY KNEE WITH THE VELYS ROBOT. WAS THERE ANY REPORTED PATIENT OR USER HARM? UNKNOWN. WAS THERE A SIGNIFICANT DELAY? NO.

VELYS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: It was reported that the surgeon believes fracture of a distal femur may have been caused by bicortical VELYS array pins causing stress riser. He mentioned that he would plan to place pins more distal and unicortical as per VELYS RAS standard pin placement. One patient treated non operatively, one patient treated with retrograde nail.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT WHILE USING THE EXCELSIUS GPS SYSTEM THERE WAS AN ISSUE WHILE CONNECTED TO A DESIGNATED RED (EMERGENCY POWER) OUTLET, THE ROBOT UNEXPECTEDLY SHUT DOWN WITHOUT WARNING. AFTER ATTEMPTING TO POWER THE SYSTEM USING MULTIPLE OUTLETS THROUGHOUT THE HOSPITAL, WE WERE STILL UNABLE TO MAINTAIN POWER. THE PLUG INDICATOR LIGHT DOES NOT ILLUMINATE WHEN CONNECTED, AND THE BATTERY INDICATOR ONLY FLASHES. AS A RESULT, THE ROBOT CANNOT BE KEPT POWERED ON. WE WERE FORCED TO ABORT THE PROCEDURE AND CANCEL MULTIPLE SCHEDULED CASES OVER THE NEXT SEVERAL DAYS.

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 AN EXCELSIUSGPS SURGERY A S2AI SCREW WAS PLACED MEDIAL AND INFERIOR. THE NAVIGATION IMAGES SHOWED THAT THE SCREW WAS ON PLAN AND IN THE PROPER PLACE HOWEVER THAT WAS NOT THE CASE. UPON X-RAY IMAGES TO CONFIRM, THE SURGEON NOTICED THAT THE SCREW WAS MEDIAL AND INFERIOR. THE SURGEON REMOVED THE SCREW AND REPLACED THE SCREW IN THE CORRECT SPOT WITHOUT TO USE OF THE ROBOT OR NAVIGATION.

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 EGPS SURGERY THAT THE SCREW WAS FIGHTING US AS IT ADVANCED. WE DECIDED TO BACK OUT SCREW. THE SCREW WAS FIGHTING US. THERE WAS A STABILIZER FAILURE. THE SURGEON REMOVED POWER BLOCK AND USED T. WE STILL COULDN'T BACK OUT. WE NOTICED STAR TIP OF CUP DRIVER LODGED INTO THE FEMALE STAR OF SCREW. WE REMOVED ROBOT FROM FIELD. WE TOOK AN X-RAY AND THE L4 WAS LOW AND MEDIAL AND NOT IN THE PLANNED TRAJECTORY. THE SURGEON TESTED DRB RIGIDITY WITH FINGERS AND IT WAS COMPLETELY OUT OF BONE. THE SURGEON PROCEEDED TO REMOVE SCREW VIA DRILLING AROUND IT. THE SCREW WAS REMOVED. WE PROCEEDED WITH LAMI/DECOMPRESSION. WE PLACED SCREWS NON ROBOTICALLY POST DECOMPRESSION.

VELYS — 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 WITH A LIGHT OSTEOPOROSIS SUFFERED A FEMORAL FRACTURE 2.5 WEEKS AFTER A TOTAL KNEE ARTHROPLASTY PROCEDURE PERFORMED WITH THE VELYS ROBOTIC ASSISTED SURGERY SYSTEM; THE FRACTURE OCCURRED WHEN SHE STOOD UP FROM A SEATED POSITION, AND THE SURGEON SUSPECTED IT WAS CAUSED BY THE HOLES MADE BY THE VELYS ARRAY PINS. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

VELYS — 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 WITH A LIGHT OSTEOPOROSIS SUFFERED A FEMORAL FRACTURE 2.5 WEEKS AFTER A TOTAL KNEE ARTHROPLASTY PROCEDURE PERFORMED WITH THE VELYS ROBOTIC ASSISTED SURGERY SYSTEM; THE FRACTURE OCCURRED WHEN SHE STOOD UP FROM A SEATED POSITION, AND THE SURGEON SUSPECTED IT WAS CAUSED BY THE HOLES MADE BY THE VELYS ARRAY PINS. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT WHILE USING THE EXCELSIUS GPS SYSTEM, T10-L2 OPEN FUSION INSTRAOP MERGE WITH E3D, T10/T11/T12 WERE ALL MEDIAL/LATERAL MISSED SCREWS, T12 RIGHT AND LUMBAR SCREWS WERE PERFECT. T10 BILATERAL AND T11 RIGHT WERE REMOVED AND REPLACED AFTER THE SECOND E3D SPIN.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT WHILE USING THE EXCELSIUS GPS SYSTEM, THERE WAS AN ISSUE WITH THE END EFFECTOR AND ACCURACY, AND THERE WAS ALSO AN ISSUE WITH REHOMING AFTER INITIAL ACCURACY CONCERNS. WE PLANNED LEVELS L4, L5, AND S1 BUT ONLY COMPLETED THE LEVELS L4, L5 DURING THE PROCEDURE. ALL 4 SCREWS WERE NOT PLACED AS PLANNED; THEY WERE ALL CONSIDERED LOWER THAN THE INITIAL PLAN THE SURGEON CREATED. THEN WE DID X-RAYS AND CONFIRMED THE SCREWS WERE OUT OF PLACEMENT. ROBOT WAS REMOVED FROM THE PROCEDURE ARE BUT STILL IN THE OR UNTIL THE CASE WAS COMPLETED.

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 THERE WAS A RADIAL ERROR OF GREATER THAN 1.5MM AT MULTIPLE TRAJECTORIES. THE RIGHT OF ELECTRODE WAS REMOVED AND NO OTHER ELECTRODE WAS PLACED ALONG THIS PLANNED TRAJECTORY. NO FURTHER REVISION IS NEEDED.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT WHILE PLACING CRANIAL LEADS WITH THE EXCELSIUS GPS THE LEFT SIDE LEAD SHIFTED SUPERIOR AT THE VENTRICLE. THE SURGEON STATED THAT THE LEAD RAN ALONG THE SUPERIOR EDGE OF THE HIPPOCAMPUS BUT DECIDED TO PLACE THE LEAD AGAIN. THE EGPS WAS PUSHED BACK IN AFTER LMCS VERIFIED CONTINUED ACCURACY. THE EGPS ARM WAS ALIGNED TO THE LEFT TRAJECTORY AND THE PROCESS REPEATED. THE O-ARM WAS BROUGHT BACK IN AND THE SPIN WAS PERFORMED AND TRANSFERRED. THE LEAD WAS FOUND TO HAVE HIT THE VENTRICLE AND SHIFTED SUPERIOR AGAIN BUT WAS INFERIOR TO THE PREVIOUS LEAD PLACEMENT AND WAS THUS MORE ON TRAJECTORY. THE SURGEON WAS SATISFIED WITH THE PLACEMENT AND CLOSING BEGAN.

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 AN EXCELSIUSGPS SURGERY THE FIRST SCREW LOOKED TO PLAN. THE SECOND SCREW, L4R, LOOKED LIKE IT WAS TO PLAN, BUT THE OFFSET WAS RED, AND DOC WAS WORRIED. THERE WERE NO NAV SHIFTS AFTER LANDMARK CHECK. HE DIDN'T LIKE, CAME BACK IN WITH DURA PRO, PUT IN SCREW AGAIN, BUT THIS TIME WAS LATERAL. HE DID A LANDMARK CHECK, EVERYTHING ACCURATE. HE DID THE SCREW FREEHAND NAV, WHICH WAS TO PLAN. THE L4L SCREW OFFSET WAS RED, AND SCREW LOOKED LATERAL, BUT DOC SAID THAT IT FELT GOOD TO HIM AND DURA PRO WAS GREEN AND RIGHT ON TRAJECTORY. THE SCREW WAS LATERAL. IT WAS POSSIBLY LATERAL DUE TO RETRACTOR, OR PATIENT MOVEMENT. THE DR. TOOK OUT SCREW, AND REPLACED SCREW FREEHAND WITHOUT NAVIGATION USING FLOUROSCOPY. ALL SCREWS TO PLAN AT END.

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 THE SURGEON'S EGPS 1L L5/S1 PLIF ON A GRADE 1 SPONDYLOLISTHESIS PATIENT. THEY PLANNED PEDICLE SCREWS RELATIVELY STRAIGHT ON, AS HE INTENDED A MIDLINE INCISION. THE SURGEON APPROVED THE PLAN. THEY PLACED THE LONG QUATTRO SPIKE AND LONG SURVEILLANCE MARKER DUE TO PATIENT HYPERLORDOSIS, AND PERFORMED THE MERGE, WHICH WAS APPROVED. THEY BROUGHT IN THE ROBOT AND MARKED THE SKIN, BUT THE SURGEON SWITCHED TO MINI WILES INCISIONS. BETWEEN THE MERGE AND SCREW INSERTION, THE SURGEON BUMPED EITHER THE SM OR DRB TWICE, SHIFTING THE RED MARKER. HE VERIFIED NAVIGATION ACCURACY USING THE CHICKEN FOOT ALONG THE QUATTRO BASE, SM, AND SPINOUS PROCESS BEFORE RE-REGISTERING THE SM. THE RIGHT L5 SCREW FAILED TO PENETRATE THE POSTERIOR VB WALL, SO THEY PLACED RIGHT S1 FIRST TO CHECK DRILL SHARPNESS, THEN CHANGED TO A NEW DRILL. THE LEFT L5 AND S1 SCREWS WERE PLACED NEXT. THE POST-OP X-RAYS SHOWED LEFT L5 COMPLETELY OUT OF THE PEDICLE IN AP BUT PERFECT LATERALLY. THEY PERFORMED ANOTHER MERGE, APPROVED BY THE SURGEON, AND REPLACED LEFT L5.

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 CASE WAS A T11-L3 PERC SPINE FUSION WITH A SPINE TUMOR AT L1. WE PLACED THE DRB IN THE RIGHT PSIS AND THE SURVEILLANCE IN THE LEFT ILIAC CREST. AFTER THE FIRST SPIN WHEN DR. (B)(6) CLICKED ON HIS FIRST SCREW HE NOTED THAT THE NAV WAS WAY OFF (TOWARDS THE PATIENTS MIDLINE). IT WAS DISCOVERED AT THIS TIME THAT THE SURVEILLANCE WAS NOT SET PRIOR TO SPINNING SO WE WANTED TO PLAY IT SAFE AND RE SPIN. AFTER RESPINNING WE PLACED THE T12, L2 AND ONE L3 SCREW ON THE LEFT AND WHEN WE WENT TO PLACE THE L3 SCREW ON THE RIGHT HE NOTED THAT THE NAV WAS WAY OFF AGAIN. THIS TIME THE SURVEILLANCE HAD BEEN PROPERLY SET AND WAS STILL GREEN. THEN WE MOVED THE DRAPE NORTH (THE PATIENTS T11 ENTRY POINT WAS PREVIOUSLY NOT DRAPED OUT ENOUGH TO ACCESS) AND RE SPUN AGAIN. IMMEDIATELY AFTER THE 3RD SPIN WHEN HE WENT TO CHECK ACCURACY, HE NOTED THAT IT WAS AGAIN OFF AND THAT HE DIDN'T TRUST THE NAV MOVING FORWARD. THE SURVEILLANCE WAS ALSO STILL GREEN AT THIS TIME AS WELL.

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 THE SURGEON HAS HAD ISSUES WITH ACCURACY WHEN PLACING THE DRILL IN END EFFECTOR. OUR PLANS LOOK REALLY GOOD AND THEN THIS CHANGES WHEN A DRILL IS PLACED IN END EFFECTOR. THE TRAJECTORY IS WAY OFF AND MEDIAL FROM CHOSEN PLAN. WE DID EVERYTHING THAT CSR RECOMMENDED TO TROUBLE SHOOT, BUT THE PROBLEM PERSISTED. AFTER ATTEMPTING TO TROUBLESHOOT IS WHEN WE ABORTED SCREW INSERTION.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT SCREWS USING THE EXCELSIUS GPS SYSTEM A SCREW WAS MISPLACED DURING A PROCEDURE WITH EGPS. THE SURGEON FOUND OUT VIA POST-OPERATIVE CT, BEFORE THIS THERE WAS NO AWARENESS THAT THERE HAD BEEN A MISPLACED SCREW. CASE WAS AN MIS TRAUMA STABILIZATION FOR T12 FRACTURE, T10, 11, L1 AND L2 INSTRUMENTS. THE SCREWS IN QUESTION WERE AN L2 RIGHT PEDICLE SCREW, BREACHING MEDIALLY AND AN L2 LEFT PEDICLE SCREW BREACHING LATERALLY. SURGEON STATED THAT PATIENT DIDN'T EXHIBIT ANY NEUROLOGICAL DEFICIT HOWEVER THE SCREWS NEEDED TO BE REVISED. WE JUST COMPLETED REVISION SURGERY AND CONFIRMED CORRECT PLACEMENT OF L2 SCREWS AND EXTENDING DOWN TO L3. SCREW PLACEMENT CONFIRMED WITH INTRA-OPERATIVE CONE BEAM CT. SURGEON WAS UNSURE AND WASN'T ABLE TO POINT SPECIFICALLY TO ANY SIGNIFICANT EVENT E.G. FRAME SHIFT THAT WOULD HAVE CONTRIBUTED TO THE DEVIATION, SHE STATED THAT THE PATIENT HAD VERY SCLEROTIC BONE AND TISSUE AND THIS MAY HAVE MECHANICALLY PULLED THE SCREWS OFF COURSE, SHE STATED THAT INSERTING THE SCREWS WAS "TOUGH" AND WAS CONSTANTLY FIGHTING FORCES. THE PATIENT ALSO HAD VERY NARROW PEDICLES, AND INSTRUMENTATION WAS GOING TO BE CHALLENGING IN ANY SCENARIO. I WASN'T PRESENT IN T

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 IS SUFFERING PARAPLEGIA POST EGPS SURGERY. THE SURGEON IMPLIED HE FELT EGPS INSTRUMENTATION MAY HAVE CONTRIBUTED TO THE OUTCOME. SEPARATE CASE SUMMARY SUBMITTED DETAILING OBSERVED SURGICAL EVENTS. FROM INITIAL INFORMATION GATHERING WE HAVE BEEN INFORMED THAT THERE APPEARS TO BE HEMATOMA AND BONE FRAGMENTS IN THE CANAL SPACE AT AROUND THE T9 ANATOMICAL AREA. FROM CONVERSATIONS WITH THE CLINICIAN'S SURGICAL IMPLANTATION FROM THE PROCEDURE APPEARS TO BE CORRECTLY POSITIONED AND IMPLANT ACCURACY APPEARS TO NOT BE IN QUESTION. INITIAL REPORTING FROM THE SURGEON USER APPEARED TO INDICATE HE FELT THAT THE HIGH-SPEED DRILL OR THE PILOT DRILL COULD HAVE MOVED BONE FRAGMENTS INTO THE CANAL AT THIS AREA. IT IS UNCLEAR WHETHER THERE IS ANY EVIDENCE OF INSTRUMENTATION BREACH E.G. CLEARLY DEFINED INSTRUMENT TRACKS, INTO THE CANAL, HOWEVER THE SUGGESTION APPEARED TO BE THE SURGEON FELT THAT THESE INSTRUMENTS MAY HAVE MECHANICALLY DISLODGED THE BONY ANATOMY AND HAD A CAUSATIVE EFFECT.

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 SINGLE POSITION LATERAL USING EGPS AND AIRO. L3-S1 FIXATION WITH L3-4 L4-5 LATERAL FUSION. THERE WERE HIGH SKIVE WARNINGS ON R L4 SCREW INSERTION. THE SCREW PLACED SLIGHTLY SUPERIOR AND LATERAL TO PLAN. THE SURGEON ATTEMPTED TO PLACE SCREW MULTIPLE TIMES AND EACH ATTEMPT GAVE HIGH SKIVE WARNINGS DESPITE HS DRILL AND SIDE CUTTING DRILL FOLLOWING TRAJECTORY. IT WAS NOT TAPPED. THERE WERE NO SURVEILLANCE WARNINGS. IT WAS THEIR FIRST CASE WITH EGPS 6.1 SOFTWARE USING RELINE SCREWS. THE R L5 SCREW HAD SIMILAR ISSUE AND WAS FINALLY PLACED OVER K-WIRE. (AWL - K-WIRE - NON-NAVIGATED DRIVER) ON AIRO SCAN REVIEW THE R L4 SCREW WAS PLACED SLIGHTLY SUPERIOR AND LATERAL TO PLAN. SCREW WAS REMOVED AND NOT REPLACED. THE PATIENT SHOWED NO ADVERSE EFFECTS FROM MISPLACED SCREW.

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 DR. (B)(6) USED THE EXCELSIUS ROBOT (INTRA-OP WORKFLOW) FOR A T11-L1 POSTERIOR LATERAL FUSION. IT IS TO BE NOTED HE ONLY PLACED PEDICLE SCREWS AT T11AND L1 SKIPPING T12 DUE TO A TUMOR SURROUNDING THE T12 VERTEBRAL BODY. DR. (B)(6) DECIDED TO PERFORM HIS DECOMPRESSION THROUGH A POSTERIOR MIDLINE INCISION PRIOR TO PLACING PEDICLE SCREWS BECAUSE HE WANTED TO KNOW HOW FAR THE TUMOR HAD SPREAD. DR. (B)(6) WANTED TO USE THE DRB AND SURVEILLANCE MARKER AND PLACED THEM IN THE PSIS AFTER DECOMPRESSION. AFTER SCREWS WERE PLACED AND ANOTHER CT SCAN WAS PERFORMED VIA E3D THE PEDICLE SCREWS ON THE PATIENT'S RIGHT SIDE WERE MEDIAL OF THE PLANNED TRAJECTORY. LEFT PEDICLE SCREWS WERE IN THE PROPER TRAJECTORY. SURVEILLANCE SHOWED THAT THE DRB HAD NOT MOVED DURING THE CASE. DR. HAMILTON REMOVED THE RIGHT SCREWS AND IMPLANTED THEM FREEHAND. HE ADVISED HE DID NOT SEE ANY DURAL LEAKS AND LATER TOLD US THE PATIENT WAS DOING WELL.

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 THE REGISTRATION PROCESS, HD INTRAOPERATIVE 3D SPIN WAS USED FOR REGISTRATION. AFTER THE SPIN WAS COMPLETED, AN XRAY GENERATOR FAILURE POP UP WAS OBSERVED. THE SCAN ACQUIRED WAS UNUSABLE, WHITED OUT AND GRAINY. THE SURGEON ABANDONED E3D AND ROBOT FOR THE DURATION OF THE CASE. ADDITIONALLY, AUTO REGISTRATION FAILED AND SCAN DID NOT PUSH OVER TO ROBOT AUTOMATICALLY.

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 THE CANNULA WAS INSERTED INTO THE CENTER TRAJECTORY, MER TESTING WAS PERFORMED. THE CANNULA WAS THEN MOVED TO THE MEDIAL TRAJECTORY. HOWEVER, RESULTS WERE NOT AS DESIRED AND THE TARGET WAS MOVED 3MM MEDIAL FROM THE ORIGINAL CENTER TRAJECTORY. THE LEAD WAS PLACED. DURING TESTING, IT WAS DECIDED TO MOVE THE CANNULA/LEAD TO THE POSTERIOR TRAJECTORY. AT THIS POINT, THE PATIENT APPEARED TO HAVE A STROKE AND THE PATIENT WAS CLOSED AND TAKEN TO THE ER. FOLLOW UP WITH THE SURGEON REVEALED THAT THERE WERE TWO BLEEDS UNILATERALLY ON THE RIGHT AT THE INTERNAL CAPSULE. THE SURGEON STATED THAT EVERY TRACK PLACED IS A 1% RISK OF THIS OCCURRING (4 TOTAL TRACKS ON RIGHT SIDE). THE LAST INFORMATION RECEIVED WAS THAT THEY WERE WAKING THE PATIENT UP, BUT IT IS UNKNOWN IF ANY DEFICITS ARE TEMPORARY AT THIS TIME.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED AND REVISED INTRA-OPERATIVELY.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED AND REVISED INTRA-OPERATIVELY.

VELYS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: POPLITEAL ARTERIA INJURY WHILE USING VELYS DURING A KNEE ARTHROPLASTY. THE SURGEON EXPLAINED THAT THEY DID NOT USE RETRACTORS AS USUAL FOR A RECUT AND FACED A POPLITEAL ARTERIA INJURY. THEY MADE A SUTURE DIRECTLY ON THE ARTERIA TO STOP THE BLEEDING AND THE PATIENT HAD NO MAJOR HEMORAGIA, AND NO OTHER VASCULAR SURGERY NEEDED. ARTHERIOGRAPHY WAS DONE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A FIFTEEN MINUTE DELAY. PATIENT RECEIVED SURVEILLANCE IN THE ICU FOR A NIGHT AND A PLATELET-INHIBITING AGENT.

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 AN EXCELSIUS GPS SURGERY THERE WAS A L4 ACCURACY ISSUE WITH PLACEMENT OF THE SCREW. THE SCREW WAS REMOVED AND REPLACED.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE FOLLOWING ARTICLE HAS BEEN REVIEWED: MCNIERNEY D, CHEN J, ZEIN JG, VASZAR L, SWANSON K, AZADEH N, SAKATA KK. COMPARING MONARCH VERSUS ION ROBOTIC-ASSISTED BRONCHOSCOPY PLATFORMS: A PROPENSITY SCORE-MATCHED ANALYSIS. J BRONCHOLOGY INTERV PULMONOL. 2025 JUL 15;32(4):E01019. DOI: 10.1097/LBR.0000000000001019. PMID: 40662912, AND CITED FOUR (4) INSTANCES OF PNEUMOTHORAX WITH CHEST TUBE PLACEMENT. THIS REPORT IS BEING SUBMITTED FOR THESE EVENTS.

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 PROCEDURE, THE PHYSICIAN ENCOUNTERED CART BOOT UP ISSUE AND ELECTED TO ABORT THE CASE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT THE SURGERY WAS PERFORMED AT THE L3-4 SITE, INSTEAD OF THE L3-5 SITE. THIS WAS NOT DISCOVERED DURING THE SURGERY OR DURING THE PATIENT'S STAY IN THE HOSPITAL. UPON THE PATIENT'S RETURN VISIT, HE WAS ADVISED BY THE SURGEON THAT THE SURGERY WAS PERFORMED AT THE WRONG LEVEL. AN ADDITIONAL SURGERY AT THE CORRECT SITE WAS SCHEDULED FOR ON (B)(6) 2025. THE PATIENT CLAIMS TO HAVE SEVERE PAIN, DIFFICULTY IN AMBULATING AND FOOT DROP.