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 DIFFICULTY NAVIGATING 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 SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED AND ADJUSTED INTRA-OPERATIVELY.

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 THE BRONCHOSCOPY PROCEDURE, THE PATIENT DEVELOPED MEDIASTINAL EMPHYSEMA, AS INDICATED BY THE POSTOPERATIVE CT EXAMINATION. AFTER A FOLLOW-UP CT SCAN DEMONSTRATED RECOVERY, THE PATIENT WAS DISCHARGED ON (B)(6), FOLLOWING A TOTAL HOSPITAL STAY OF 6 DAYS.

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 SYSTEM FAULT MESSAGES AND ELECTED TO ABORT THE CASE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

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 ROBOTIC BRONCHOSCOPY PROCEDURE, THE PATIENT HAD A PNEUMOTHORAX. A CHEST TUBE WAS PLACED AND THE PATIENT WAS MONITORED. THE PNEUMOTHORAX RESOLVED AND THE PATIENT WAS DISCHARGED HOME SIX DAYS AFTER THE PROCEDURE.

ROSA Robotic Surgery — 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 OVER RESECTION ON BOTH THE DISTAL FEMORAL AND PROXIMAL TIBIAL RESECTIONS, WITH A NET OVER RESECTION OF 4MM. THE CALIPER OF BONE MATCHED VALIDATED CUTS. PLANNED POLY WAS 10MM, RESULTING IN 13MM POLY WITH ADDITIONAL SOFT TISSUE RELEASES. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

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 (VIA MEDSUN UF/IMPORTER REPORT # (B)(4)) THAT AFTER THE MONARCH BRONCHOSCOPY PROCEDURE THE PATIENT EXPERIENCED A PNEUMOTHORAX.

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 PROCEDURE THE PHYSICIAN WAS UNABLE TO TURN THE BRONCHOSCOPE ON AFTER REMOVING THE SCOPE FROM THE PATIENT'S TRACHEA DUE TO THE CAMERA IMAGE BEING GRAINY AND ULTIMATELY GOING BLACK. THE PHYSICIAN ELECTED TO ABORT THE CASE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: I LIVE WITH THE CHIEF TECHNOLOGY OFFICER FOR (B)(4), A DISTRIBUTORSHIP IN THE SOUTHEAST, FOR ZB CORPORATE. I HAVE OVERHEARD BUSINESS CALLS OF HOW THERE IS A PROBLEM WITH THE SOFTWARE ON THE ROBOTS AND THEY HAVE BEEN MAKING INCORRECT CUTS AND INCORRECT PLACEMENT OF IMPLANTS INTO PATIENTS FOR MONTHS. IT¿S A SYSTEM WIDE PROBLEM NOT JUST A FEW ROBOTS, MANY ROBOTS THEY HAVE OVER THE US ARE MALFUNCTIONING AND THEY HAVE YET TO FIGURE OUT THE EXACT CAUSE. IT¿S GONE AS HIGH UP THE CHAIN AS THE CEO BUT NOTHING IS BEING DONE. THEY HAVEN¿T SHUT DOWN USE. THEY JUST KEEP DOING INCORRECT AND IMMORAL SURGERIES ON PATIENTS AND NOT INFORMING THE DOCTORS THAT THEIR ROBOTS ARE THE REASON FOR THE POOR SURGERIES AND RESULTS. THEY HAVE BEEN TRYING TO FIX THE ISSUE AND COVER IT UP SINCE ZB FIRST BECAME AWARE. AS OF RIGHT NOW IT¿S NOT FIXED AND THEY ARE LETTING SURGEONS CONTINUE TO MAKE HARMFUL, PAINFUL IMPLANTS INTO PATIENTS. THEY¿VE FIRED ANYONE THAT CAME CLOSE TO DISCOVERING THE ISSUE. I LIVE WITH THE CHIEF TECHNOLOGY OFFICER FOR (B)(4), THE DISTRIBUTORSHIP FOR ZIMMER BIOMET IN THE SOUTHEAST DIVISION. THE ROSA ROBOT SOFTWARE HAS BEEN MALFUNCTIONING AND MAKING MISCUTS CONSTANTLY AND CAUSING HARM TO PATIE

VELYS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: THE FRACTURE WAS CAUSED BY FAILURE TO CLEAR THE POSTERIOR ASPECT OF THE PS BOX. NETHER THE VELYS CUTS OR THE SAGITTAL SAW CUTS WERE THE BLAME.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: I LIVE WITH THE CHIEF TECHNOLOGY OFFICER FOR (B)(6), A DISTRIBUTORSHIP IN THE SOUTH EAST, FOR ZB CORPORATE. I HAVE OVERHEARD BUSINESS CALLS OF HOW THERE IS A PROBLEM WITH THE SOFTWARE ON THE ROBOTS AND THEY HAVE BEEN MAKING INCORRECT CUTS AND INCORRECT PLACEMENT OF IMPLANTS INTO PATIENTS FOR MONTHS. IT¿S A SYSTEM WIDE PROBLEM NOT JUST A FEW ROBOTS, MANY ROBOTS THEY HAVE OVER THE US ARE MALFUNCTIONING AND THEY HAVE YET TO FIGURE OUT THE EXACT CAUSE. IT¿S GONE AS HIGH UP THE CHAIN AS THE CEO BUT NOTHING IS BEING DONE. THEY HAVEN¿T SHUT DOWN USE. THEY JUST KEEP DOING INCORRECT AND IMMORAL SURGERIES ON PATIENTS AND NOT INFORMING THE DOCTORS THAT THEIR ROBOTS ARE THE REASON FOR THE POOR SURGERIES AND RESULTS. THEY HAVE BEEN TRYING TO FIX THE ISSUE AND COVER IT UP SINCE ZB FIRST BECAME AWARE. AS OF RIGHT NOW IT¿S NOT FIXED AND THEY ARE LETTING SURGEONS CONTINUE TO MAKE HARMFUL, PAINFUL IMPLANTS INTO PATIENTS. THEY¿VE FIRED ANYONE THAT CAME CLOSE TO DISCOVERING THE ISSUE. I LIVE WITH THE CHIEF TECHNOLOGY OFFICER FOR (B)(6), THE DISTRIBUTORSHIP FOR ZIMMER BIOMET IN THE SOUTHEAST DIVISION. THE ROSA ROBOT SOFTWARE HAS BEEN MALFUNCTIONING AND MAKING MISCUTS CONSTANTLY AND CAUSING HARM TO PATI

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 SYSTEM FAULT MESSAGES 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 SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED 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 INTRA-OPERATIVELY AND THEN 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: IT WAS REPORTED THAT DURING A MONARCH BRONCHOSCOPY PROCEDURE THE PHYSICIAN WAS UNABLE TO QUERY PACS (PICTURE ARCHIVING AND COMMUNICATION SYSTEM) 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 SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED.

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 INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED. THIS EVENT OCCURRED IN SPAIN.

ROSA Robotic Surgery — 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 INITIAL ROSA CEMENTLESS VANGUARD PS WAS PERFORMED WITH UNKNOWN INTRA-OPERATIVE PROBLEM. ON THE POST-OPERATIVE X-RAY, A COLLAPSE OF THE MEDIAL PLATEAU WAS SEEN AND A REVISION WAS PLANNED. DUE DILIGENCE IS IN PROGRESS FOR THIS EVENT; AT THIS TIME NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

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 SYSTEM FAULT MESSAGES 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 SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: PLUGGED THE EGPS INTO THE MAINS POWER SUPPLY AND NOT RECEIVING ANY POWER, TRIED MULTIPLE SOCKETS BUT NO POWER.

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, THE CASE WAS ABORTED DUE TO ROBOTIC ERROR, AND SCREWS WERE THEN PLACED WITHOUT ROBOT.

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 INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED.

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 INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED.

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 INTRA-OPERATIVELY AND THEN REMOVED.

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 ROBOTIC ERROR TOOK OVER 40 MINUTES TO RESOLVE WITH THE PATIENT UNDER ADDITIONAL ANESTHESIA.

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 INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED.

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 INTRA-OPERATIVELY AND POST OP CT SCAN SHOWS A MEDIAL BREACH OF THE L4 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 WHILE USING THE EXCELSIUS GPS SYSTEM, THE CASE WAS ABORTED DUE TO ROBOT NOT POWERING ON.

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, THE CASE WAS ABORTED DUE TO ROBOTIC ERROR, AND SCREWS WERE THEN PLACED WITHOUT ROBOT.

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 INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED.

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 INTRA-OPERATIVELY AND THEN REMOVED.

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 INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED.

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 INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED.

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 INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED.

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 INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED.

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, THE CASE WAS ABORTED DUE TO THE ROBOT BECOMING UNRESPONSIVE, AND SCREWS WERE THEN PLACED WITHOUT ROBOT.

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 INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED.

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 INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED.

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, THE CASE WAS ABORTED DUE TO MERGE ISSUE.

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 DURING A TOTAL KNEE ARTHROPLASTY SURGICAL PROCEDURE, IT WAS OBSERVED THAT WHILE USING THE ROBOTIC-ASSISTED SOLUTION SATELLITE STATION DEVICE A CUT WAS MADE "THAT WAS NOT APPROPRIATE." IT WAS REPORTED THAT WHILE PLACING THE IMPLANT THE ANTERIOR CUT WAS OFF. IT WAS REPORTED THAT A REVISION HAD TO BE MADE TO THE IMPLANT AND THE CONDYLE WAS FRACTURED DURING THE CASE. IT WAS REPORTED THAT THE POINTER HAD NOT BEEN USED FOR VERIFICATION. IT WAS REPORTED THAT THE CUT ON THE FEMUR HAD NOTCHED THE ANTERIOR CORTEX. IT WAS REPORTED THAT THE DEVICE WAS BEING USED WITH A ROBOTIC ASSISTED BASE STATION DEVICE. THERE WERE NO DELAYS IN THE PROCEDURE. THERE WAS PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. THIS IS REPORT 1 OF 2 FOR (B)(4).

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 INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED.

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 DURING A TOTAL KNEE ARTHROPLASTY SURGICAL PROCEDURE, IT WAS OBSERVED THAT WHILE USING THE ROBOTIC-ASSISTED SOLUTION SATELLITE STATION DEVICE A CUT WAS MADE "THAT WAS NOT APPROPRIATE". IT WAS REPORTED THAT WHILE PLACING THE IMPLANT THE ANTERIOR CUT WAS OFF. IT WAS REPORTED THAT A REVISION HAD TO BE MADE TO THE IMPLANT AND THE CONDYLE WAS FRACTURED DURING THE CASE. IT WAS REPORTED THAT THE POINTER HAD NOT BEEN USED FOR VERIFICATION. IT WAS REPORTED THAT THE CUT ON THE FEMUR HAD NOTCHED THE ANTERIOR CORTEX. IT WAS REPORTED THAT THE DEVICE WAS BEING USED WITH A ROBOTIC ASSISTED BASE STATION DEVICE. THERE WERE NO DELAYS IN THE PROCEDURE. THERE WAS PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. THIS IS REPORT 2 OF 2 FOR (B)(4).

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 AFTER THE MONARCH BRONCHOSCOPY CASE WAS COMPLETED SUCCESSFULLY PATIENT EXPERIENCED A PNEUMOTHORAX SAME DAY. CHEST TUBE IS BEING EMPLANED TO ADDRESS PNEUMOTHORAX. PHYSICIAN DOES NOT ATTRIBUTE THIS EVENT TO MONARCH AND CONSIDERS IT A NORMAL RISK OF A PLURAL TARGET.

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 INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED.

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 INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED.

The consent order addresses Cruise's failure to disclose the details of an October 2023 incident in which a Cruise vehicle, operating autonomously, dragged a pedestrian several feet before coming to a stop. According to NHTSA's press release, Cruise will pay a total monetary penalty of $1.5 million, and is required to submit to NHTSA a corrective action plan on how it will improve its compliance with the Standing General Order.

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 INTRA-OPERATIVELY AND THEN REMOVED.

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, THE CASE WAS ABORTED AND SCREWS WERE THEN PLACED 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 EXCELSIUS GPS SYSTEM, THE CASE WAS ABORTED AND SCREWS WERE THEN PLACED WITHOUT ROBOT.