da Vinci Surgical System — Death 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 da Vinci-assisted sliding hiatal hernia procedure, after sealing and cutting of an unspecified branch of the aorta, bleeding occurred and the patient ultimately expired.The surgeon reported that the Vessel Sealer Curved (VSC) instrument seal and cut cycle worked as expected with no error messages. However, when the jaws of the VSC were opened, the sealed branch started to hemorrhage. The procedure continued robotically for approximately one hour in attempts to fully stop the bleeding which was able to be controlled at multiple points after the initial seal. The estimated blood loss during the robotic portion was approximately 2 liters when a mass transfusion protocol was initiated and the procedure was converted to a thoracotomy but the surgeon was unable to control the bleeding. The aorta was then cross-clamped and the bleeding stopped; however, the patient expired in the operating room. The surgeon reports there were no error messages or robotic-related complications that occurred during the procedure. Specifically, the VSC worked as expected with no error messages or complications with sealing during use.

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.

da Vinci Surgical System — Death 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 DA VINCI-ASSISTED UNSPECIFIED COLORECTAL PROCEDURE, THE INFERIOR MESENTERIC ARTERY (IMA) WAS SEALED WITH THE VESSEL SEALER CURVED (VSC) INSTRUMENT AND BLEEDING OCCURRED AFTER SEALING AND CUTTING. THE PATIENT LATER EXPIRED ON POSTOPERATIVE DAY 3. THE SURGEON REPORTED THAT WHEN THE JAWS WERE OPENED, BLEEDING WAS IMMEDIATE. THE IMA HAD AN OPEN LUMEN AND SHOWED NO SIGNS OF SEALING. THE VSC CONTINUED TO BE USED TO SEAL THE IMA TWO MORE TIMES ALONG DIFFERENT POINTS DURING THE PROCEDURE; BLEEDING OCCURRED AFTER EACH SEAL. THE VESSEL HAD TO BE RE-SEALED MORE PROXIMALLY TOWARD THE AORTA TO MOBILIZE THE TISSUE TO CREATE AN OSTOMY. THE SEALING TONES WERE REPORTED AS APPROPRIATE AND NO ERROR MESSAGES WERE PRODUCED WHILE SEALING. THE ESTIMATED BLOOD LOSS WAS 300ML. AFTER THE ROBOTIC PORTION WAS COMPLETED AND DURING CLOSURE, THE PATIENT CODED. RESUSCITATION MEASURES WERE SUCCESSFUL, AND THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT. THE PATIENT EXPIRED THREE DAYS LATER AFTER THE FAMILY DECIDED TO WITHDRAW CARE. THE SURGEON RELATED THE VSC INABILITY TO SUCCESSFULLY SEAL MULTIPLE TIMES THROUGHOUT THE PROCEDURE TO CHALLENGING TISSUE INTEGRITY DUE TO EDEMA. THE

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.

da Vinci Surgical System — Death 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 DA VINCI-ASSISTED MEDIAN ARCUATE LIGAMENT SYNDROME RELEASE (MALS) PROCEDURE, THE PATIENT EXPERIENCED INTRAOPERATIVE BLEEDING FROM THE AORTA AND ULTIMATELY EXPIRED. THE VESSEL SEALER CURVED (VSC) INSTRUMENT WAS BEING USED FOR BLUNT DISSECTION AND CAUTERY WHEN SIGNIFICANT BLEEDING OCCURRED FROM THE AORTA. THE PROCEDURE WAS EMERGENTLY CONVERTED TO AN OPEN APPROACH. WHEN AN ASSISTING VASCULAR SURGEON CROSS CLAMPED THE AORTA DURING REPAIR ATTEMPTS, THE PATIENT¿S PULSE WAS LOST AND CHEST COMPRESSIONS WERE STARTED. WITH NO RETURN OF A PULSE, THE CROSS CLAMPS ON THE AORTA WERE REMOVED AND BLEEDING CONTINUED WITH THE CHEST COMPRESSIONS. THE PATIENT EXPIRED IN THE OPERATING ROOM. THE SURGEON STATED THAT THE CAUSE OF THE AORTIC INJURY WAS UNKNOWN. THE SURGEON REPORTED THAT THROUGHOUT THE PROCEDURE, IT WAS NOTICED THAT THE VSC PRODUCED INCREASED THERMAL SPREAD AND INCREASED BLEEDING AFTER ENERGY ACTIVATION WHEN COMPARED TO THE VESSEL SEALER EXTEND. IT WAS ALSO STATED THAT THE VSC JAW MOVEMENT WOULD OPEN A LITTLE SLOWLY AT FIRST, THEN WOULD SPRING OPEN QUICKLY, WITH INCREASED BLEEDING FROM THE FAST JAW OPENING. NO ADDITIONAL INFORMATION WAS PROVIDED.

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.

da Vinci Surgical System — Death 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 DA VINCI-ASSISTED SINGLE-PORT UNSPECIFIED ¿HEAD AND NECK¿ SURGICAL PROCEDURE, THE PATIENT DEVELOPED A POSTOPERATIVE HEMORRHAGE AND ULTIMATELY EXPIRED. THE SURGEON INFORMED THE INTUITIVE CLINICAL SALES REPRESENTATIVE THAT THE ROBOTIC PROCEDURE WAS COMPLETED WITHOUT ANY INTRAOPERATIVE COMPLICATIONS; HOWEVER, THE PATIENT DEVELOPED POST-OPERATIVE COMPLICATIONS DUE TO UNSPECIFIED BLEEDING FROM THE NON-SPECIFIC PROCEDURE. NO ADDITIONAL EVENT INFORMATION WAS PROVIDED. THE SURGEON STATED THAT THE ADVERSE EVENT ¿HAD NOTHING TO DO WITH THE DA VINCI SP SYSTEM¿. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE SURGEON WERE MADE; HOWEVER, NO RESPONSE WAS RECEIVED.

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.

da Vinci Surgical System — Death 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 DA VINCI-ASSISTED PULMONARY LOBECTOMY PROCEDURE, AN INADVERTENT PERFORATION OF THE PULMONARY ARTERY OCCURRED WHILE USING A THIRD-PARTY LAPAROSCOPIC STAPLER INSTRUMENT, RESULTING IN SIGNIFICANT HEMORRHAGE AND THE PATIENT ULTIMATELY EXPIRED. THE EXACT VOLUME OF BLOOD LOSS IS UNKNOWN. THE SURGEON DOES NOT BELIEVE THAT THE DA VINCI SYSTEM, INSTRUMENTS, OR ACCESSORIES CAUSED OR CONTRIBUTED TO THE EVENT. ADDITIONAL INFORMATION WAS REQUESTED, BUT THE CUSTOMER HAS INDICATED THAT THEY WILL NOT GRANT PERMISSION FOR FURTHER ACCESS TO THE EVENT INFORMATION.

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.