REAL INTELLIGENCE ROB10024Recalls & reported problems

Summary

The FDA's MAUDE database contains 924 adverse event reports that list this exact device (DI 00885556757420), received between Aug 3, 2020 and May 14, 2026 — classified as 191 injuries, 733 malfunctions.

The most frequently reported specific device problem is “Application Program Problem: Parameter Calculation Error” (364 reports).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. May 7, 2024Open, Classified

   CORI Surgical System with Real Intelligence Software exhibits an increased Marker Registration Error (MRE) which may cause tracker arrays to flicker on screen of the CORI Surgical System during use, and may cause surgical delay

   Z-2135-2024 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 924 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2026Application Program Problem: Parameter Calculation Error

  IT WAS REPORTED THAT, DURING CORI ASSISTED TKA SURGERY, SURGEON DISAGREED WITH THE PATIENT¿S ALIGNMENT BASED ON HIS CLINICAL JUDGEMENT, RELATIVE TO THE OUTPUT THE ROBOTIC SYSTEM WAS REPORTING. WHILE THE ROBOT SHOULD¿VE PLACED HIS FEMUR AND TIBIA IN A FEW DEGREES OF VARUS, HE CLINICALLY DETERMINED THE PATIENT¿S COMPONENTS AND OVERALL ALIGNMENT WAS VALGUS, PROMPTING HIM TO RECUT USING MANUAL INSTRUMENTATION. THE PROCEDURE WAS PERFORMED, AFTER A NON-SIGNIFICANT DELAY, CHANGING TO MANUAL PROCEDURE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25177724 ↗
• MalfunctionMay 5, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT, DURING A CORI ASSISTED TKA SURGERY, WHEN SELECTING THE TIBIAL TWIN PEG CUTTING OPTION THE SCREEN FROZE AND THE TOP OF THE TIBIA ON THE RIGHT HAND SIDE OF THE SCREEN, WHICH IS USED TO CONFIRM POSITION OF THE TIBIAL CUTTING BLOCK, COULD NOT BE SEEN. THREE ATTEMPTS WERE WERE MADE TO SHUT DOWN THE SYSTEM AND THEN TO RESUME THE CASE. HOWEVER, ON EACH ATTEMPT THE SAME PROBLEM WAS INCURRED. THE OPTION TO BURR ALL THE TIBIA WAS WORKING, BUT THE SURGEON WAS NOT HAPPY TO USE THIS CUTTING TECHNIQUE DUE TO LIMITED EXPERIENCE WITH THE SYSTEM. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE (MANUAL PROCEDURE). NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25089762 ↗
• MalfunctionMay 3, 2026Application Program Problem: Parameter Calculation Error

  IT WAS REPORTED THAT, DURING CORI ASSISTED TKA SURGERY, WHEN BURRING THE DISTAL FEMUR, THE PURPLE REMOVAL ICON WAS SELECTED. IT REMOVED THE PURPLE MODEL FROM THE DISTAL FEMUR MODEL ON THE CUT SCREEN. THE SURGEON REQUESTED THE PURPLE TO BE PUT BACK, BUT EVEN WHEN MOVING THE RESECTION +1MM ON THE PLANNING SCREEN, AND MOVING THE FEMUR MEDIAL A FEW CLICKS, THE PURPLE DID NOT RETURN. THE PROCEDURE WAS PERFORMED, AFTER A NON-SIGNIFICANT DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25064276 ↗
• MalfunctionMay 1, 2026Unintended Application Program Shut Down

  IT WAS REPORTED THAT, DURING A CORI ASSISTED SURGERY, THE REAL INTELLIGENCE CORI DISPLAYED AN ¿INTERNAL ERROR¿ MESSAGE AND DID NOT ALLOW THE PROCEDURE TO BE COMPLETED. THE SURGEON THEN PROCEEDED TO COMPLETE THE PROCEDURE USING CONVENTIONAL SURGICAL TECHNIQUES. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25058973 ↗
• MalfunctionApr 28, 2026Application Program Problem: Parameter Calculation Error

  IT WAS REPORTED THAT, DURING A REAL INTELLIGENCE CORI ASSISTED THA SURGERY, THE CORI DID NOT RECOGNIZE THE ASIS POINTS AND ACETABULUM RELATIVE TO THE PLAN. IT WAS NOT ALLOWING TO SKIP THE PELVIS AND GO ONTO "LEG SITUATION." INSTEAD, IT WAS GIVING US THE OPTION OF EITHER RE-REGISTERING THE PELVIS OR GOING RIGHT TO THE REPORT. IT IS WORTH NOTING THAT BOTH OF THESE PELVISES HAD HIGH ANTERIOR TILT NUMBERS (13+ DEGREES), SO IT WAS HARD TO GET THE ASIS POINTS REGISTERED IN THE FIRST PLACE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25013284 ↗
• MalfunctionApr 28, 2026Application Program Problem: Parameter Calculation Error

  IT WAS REPORTED THAT, DURING A REAL INTELLIGENCE CORI ASSISTED THA SURGERY, THE CORI DID NOT RECOGNIZE THE ASIS POINTS AND ACETABULUM RELATIVE TO THE PLAN. IT WAS NOT ALLOWING TO SKIP THE PELVIS AND GO ONTO "LEG SITUATION." INSTEAD, IT WAS GIVING US THE OPTION OF EITHER RE-REGISTERING THE PELVIS OR GOING RIGHT TO THE REPORT. IT IS WORTH NOTING THAT BOTH OF THESE PELVISES HAD HIGH ANTERIOR TILT NUMBERS (13+ DEGREES), SO IT WAS HARD TO GET THE ASIS POINTS REGISTERED IN THE FIRST PLACE. THEN, TRIED TO RE-REGISTER IT FOR A SECOND TIME AND ACTUALLY GOT THE PELVIS SIDE TO REGISTER, SO WE COULD USE THE CORI FOR PELVIC NUMBERS. HOWEVER, WHEN WE TRIED TO MOVE ONTO THE LEG LENGTH / OFFSET NUMBERS SCREEN IT WOULD NOT LET US, AND WOULD AGAIN GO STRAIGHT TO REPORT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25013198 ↗
• MalfunctionApr 16, 2026Application Program Freezes or Fails to Launch

  IT WAS REPORTED THAT, DURING A REAL INTELLIGENCE CORI ASSISTED THA SURGERY, DURING CUP NAVIGATION, THE CAMERA DID NOT SEE THE CUP IMPACTOR EVEN THOUGH IT WAS IN VIEW OF CAMERA, THE NAVIGATION SCREEN FROZE UP AND THE REP HAD TO RESTART THE REAL INTELLIGENCE CORI BECAUSE THE CONSOLE WAS FROZEN ON NAVIGATION SCREEN. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH MANUAL PROCEDURE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24896987 ↗
• MalfunctionApr 14, 2026Unintended Application Program Shut Down

  IT WAS REPORTED THAT, DURING A REAL INTELLIGENCE CORI ASSISTED TKA SURGERY, MADE IT TO PRELIMINARY PLANNING SCREEN (BEFORE TAKING STRESSED RANGE OF MOTION) AND SAW THAT MORE POINTS WERE NEED ON THE FEMUR. WENT BACK TO THE FEMUR MAPPING SCREEN TO ADD THOSE POINTS AND BOTH 24" TOUCHSCREEN AND TABLET SHUT DOWN. UNABLE TO CONTINUE SO WE HAD TO RESTART THE SYSTEM AND RESUME THE CASE FROM THERE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24879843 ↗
• MalfunctionMar 30, 2026Unintended Application Program Shut Down

  IT WAS REPORTED THAT, DURING A REAL INTELLIGENCE CORI ASSISTED THA SURGERY, GOT TO CUP NAVIGATION DURING THE CASE, THE PELVIS PICTURE WASN¿T NOT SHOWING UP AND THE VERSION AND INCUBATION NUMBERS WERE NOT SHOWING UP, THE CASE THEN CRASHED. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, CHANGING TO A MANUAL PROCEDURE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24724106 ↗
• MalfunctionMar 22, 2026Application Program Problem: Parameter Calculation Error

  IT WAS REPORTED THAT DURING A TKA, THE REAL INTELLIGENCE CORI LET A NOTICEABLE "ROUGH" AND/OR "RAISED" PORTION OF BONE NEAR THE INTERCONDYLAR NOTCH/SULCUS WHEN PERFORMING THE DISTAL BUR, EVEN THOUGH THE BUR SCREEN DIDN'T SHOW ANY GREEN UN-BURRED BONE LEFT. A RASP/SAW WAS USED TO CLEAR AWAY THE REMAINING BONE THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24658876 ↗
• MalfunctionMar 10, 2026Application Program Problem: Parameter Calculation Error

  IT WAS REPORTED THAT, DURING A CORI ASSISTED TKA SURGERY, WHILE TRIALING THE FEMUR AFTER ALL CUTS, IT WASN'T SEATED PROPERLY. THEY WENT BACK TO THE FEMUR BURR ALL AND PROCEEDED TO BURR AWAY THE EXCESS ANTERIOR CHAMFER. THEY REMOVED THE PURPLE AND PROCEEDED TO BURR, THE BURR WAS TAKING THE BONE BUT THE BLUE ANIMATION WAS NOT BEING TAKEN OFF THE MODEL ON THE SCREEN. AFTER REALIZING THAT SOMETHING WAS WRONG, THEY WENT IN REFINE MODE. THEY TRACED THE ENTIRE FEMUR AND NO BLUE WAS SUBTRACTED OFF THE BONE MODEL ON THE SCREEN. THEY ABANDONED USING THE BURR TO GET THE REMAINING BONE ON THE ANTERIOR CHAMFER AND USED MANUAL INSTRUMENTATION. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24560234 ↗
• MalfunctionMar 7, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT, DURING A REAL INTELLIGENCE CORI ASSISTED TKA SURGERY, USB PORTS ON CONSOLE DID NOT REGISTER TENSIONER. MULTIPLE TENSIONER CARTRIDGES USED AS WELL AS MULTIPLE TENSIONERS WITH NO SUCCESS. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, CHANGING TO MANUAL PROCEDURE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24541223 ↗
• MalfunctionMar 7, 2026Application Program Problem: Parameter Calculation Error

  IT WAS REPORTED THAT, DURING A REAL INTELLIGENCE CORI ASSISTED TKA SURGERY, THE SOFTWARE WAS BEHAVING NORMALLY UNTIL A TIBIAL CUT WAS PERFORMED. AFTER RETURNING TO THE PLANNING SCREEN AND MODIFYING THE TIBIAL PLAN BY A FEW MILLIMETERS, THE CUT SELECTION SCREEN WAS ACCESSED; HOWEVER, THE MAIN GRAPHIC OF THE BONE MODEL WITH THE CUT SELECTION APPLIED WAS MISSING. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24540976 ↗
• MalfunctionFeb 27, 2026Application Program Problem: Parameter Calculation Error

  IT WAS REPORTED THAT, DURING A CORI ASSISTED TKA SURGERY USING ONE (1) REAL INTELLIGENCE CORI, PLANE VISUALIZER WAS PLACED IN CUT SLOT FOR SHARKBITE, AND AFTER DIALING IN AS CLOSE ¿0¿ OR AS CLOSE TO PLAN, SLOPE CONTINUOUSLY WOULD INCREASE 3+ DEGREES FROM WHAT WAS INITIALLY PLANNED AS PINS WERE BEING PLACED INTO CUT SLOT. IT WAS DECIDED TO TAKE A DEGREE ¿LESS¿ FROM WHAT WAS PLANNED AND AFTER MAKING TIBIAL CUTS WITH THE SAW, PLACED VISUALIZER BACK ON TIBIA AND IT SHOWED SURGEON TOOK 8+ MORE OF SLOPE FROM PLAN. THEN, IT WAS ATTEMPTED A CLEAN-UP CUT WITH THE BUR TO ENSURE IT WAS ACCURATE TO PLAN AND IT SHOWED IT WAS DEEP ON THE MEDIAL SIDE OF THE TIBIA. THEN, DROPPED THE TIBIA 1MM TO ENSURE IT HAD A FLAT SURFACE. ONCE THAT CUT WAS COMPLETED, THE PLANE VISUALIZER WAS PLACED BACK ON THE TIBIA TO SHOW THEY WHERE ACCORDING TO PLAN, BUT THE REPORTED CONSOLE SHOWED IT WAS 8+ MM BELOW PLAN. FINALLY, ONCE TRIALING WAS BEGAN, POSTOP ROM AND STRESSED GAP CHECK WERE TAKEN. THE GAPS SHOWED EXTREMELY LOOSE MEDIALLY AND TIGHTER LATERALLY AFTER WE HAD PLANNED TO BE CLOSE TO 0 MEDIALLY WITH ABOUT 2+MM OF LAXITY LATERALLY. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED. THE PROCEDURE WAS RESUMED AFTER A

  Patient problems: Laceration(s); No Clinical Signs, Symptoms or Conditions

  MAUDE report 24476705 ↗
• MalfunctionFeb 26, 2026Application Program Problem: Parameter Calculation Error

  IT WAS REPORTED THAT, DURING A CORI ASSISTED TKA SURGERY, ONE (1) REAL INTELLIGENCE CORI SHOWED A DISCREPANCY FROM WHAT WAS SEEN CLINICALLY. A 15 DEGREE VARUS ALIGNMENT WAS SHOWN AND POSTOP DATA WAS ALSO SHOWING EXTREMELY LOOSE WHEN SURGEON PLANNED TIGHT. DURING THE TENSIONING PHASE, SURGEON PREFERRED TO COLLECT AT NEUTRAL AND 90 DEGREES; HOWEVER, THE DOTTED WHITE LINES THAT SHOW THE LIVE DEGREES OF THE LEG WERE SHOWING INACCURATELY. ON THE REPORTED CONSOLE IT APPEARED THE LEG WAS AT 90 DEGREES, WHEN SURGEON DEDUCED IT WAS AT ABOUT 50 DEGREES. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24455010 ↗
• MalfunctionFeb 11, 2026Imprecision

  IT WAS REPORTED THAT, DURING A CORI ASSISTED TKA SURGERY, ONE (1) REAL INTELLIGENCE CORI DETERMINED THAT THE BONE WAS TAKEN ON THE LATERAL SIDE AND SHOWED ¿WHITE¿ SAYING WE HAD REACHED OUR TARGET RESECTION. HOWEVER, THERE WAS STILL A SIZABLE SHELF OF BONE LEFT. THE BURR DID NOT CUT THIS BONE WHEN RUNNING THE BURR OVER IT. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE (MANUAL PROCEDURE). NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24313421 ↗
• MalfunctionFeb 10, 2026Application Program Problem: Parameter Calculation Error

  IT WAS REPORTED THAT, DURING A REAL INTELLIGENCE CORI, THE 5 IN 1 CUTTING BLOCK WAS SITTING >4MM TO ANTERIOR AND COULD NOT BE MOVED DOWN TO WHERE THE CUT WAS SUPPOSED TO BE POSITIONED USING THE CORI CONSOLE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24310889 ↗
• InjuryFeb 9, 2026Application Program Problem: Parameter Calculation Error

  IT WAS REPORTED THAT, DURING A CORI REVISION TKA SURGERY, THE REAL INTELLIGENCE CORI INITIALLY SIZED THE FEMUR AS A SIZE 6, WITH MEASURED LAXITY OF 7 MM ON THE LATERAL SIDE AND 5 MM ON THE MEDIAL SIDE IN FLEXION. THE ONLY WAY TO CLOSE THE FLEXION GAP, WHILE MAINTAINING A BALANCED EXTENSION GAP, WAS TO INCREASE THE FEMORAL SIZE TO A SIZE 7 OR 8; HOWEVER, THESE SIZES DID NOT APPROPRIATELY FIT THE ANTEROPOSTERIOR (A/P) DIMENSION. AFTER REFINING THE FEMUR AND SELECTING THE ¿BUR ALL¿ OPTION, IT APPEARED RED, SUGGESTING THAT THE BURRING HAVE GONE WAY BEYOND WHAT IT WAS PLANNED. WHEN THE PLANE VISUALIZER WAS PLACED ON THE ANTERIOR PORTION OF THE FEMUR, IT INDICATED THAT THE RESECTION WAS APPROXIMATELY 7 MM BELOW THAN PLANNED. ULTIMATELY, THERE APPEARED TO BE AT LEAST 4 MM (AND LIKELY MORE) OF CEMENT BETWEEN THE ANTERIOR FLANGE OF THE FEMORAL IMPLANT AND THE ANTERIOR CORTEX. THE SURGICAL PLAN WAS ADJUSTED TO AN 18 MM POLY, WHICH CORRESPONDED TO A 15 MM POLY. ALTHOUGH THE CORI SYSTEM RECOMMENDED A SIZE 8 FEMUR, A 7 FEMUR WAS IMPLANTED. A 5 MM TIBIAL WEDGE WAS USED TO REDUCE THE GAPS, AND A 13 MM POLY WAS SELECTED, WHICH CORRESPONDED TO AN 18 MM PER CORI. THE SURGEON WAS ABLE TO FIT A 15 MM

  Patient problems: Laceration(s)

  MAUDE report 24290512 ↗
• MalfunctionFeb 4, 2026Problem with Software Installation; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT, DURING A REAL INTELLIGENCE CORI ASSISTED TKA SURGERY, THE CORI SYSTEM STARTED BUT NO TOUCH SCREEN ACTIVITY WAS PRESENT TO INITIATE CASE ACCESS. THE TABLET TOUCH SCREEN ACTIVITY WAS ALSO NOT ACTIVE. THE CABLE WAS CHANGED TO A NEW CABLE FOR MONITOR ACTIVITY, AND THE TOUCHSCREEN ON THE BOTTOM FUNCTIONING KEYS WAS ENABLED AND DISABLED, BUT NO ACTIVITY WAS OBSERVED. THE USB PORTS IN THE REAR WERE NOT ACTIVE WHEN THE 2.0 APPLICATION SOFTWARE WAS ATTEMPTED TO BE REINSTALLED, ALTHOUGH ALL USB PORTS ON THE FRONT WERE RECOGNIZED. UPON RESTART, ALL SCREEN ACTIVITY WAS ABSENT. A DIFFERENT 24-INCH MONITOR WAS TRIED, BUT THE PROBLEM STILL EXISTED. THE 2.0 SOFTWARE COULD NOT BE REINSTALLED AFTER THE LOSS OF SCREEN ACTIVITY. THE TABLET WAS LEFT IN SLEEP MODE; HOWEVER, IT WAS CONFIRMED TO WORK ON ANOTHER CONSOLE. THE CONSOLE IS NOT COMPLETELY SHUT DOWN WHEN THE CORI SYSTEM IS LOGGED OFF. THE SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH MANUAL PROCEDURE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24264873 ↗
• MalfunctionFeb 2, 2026Application Program Problem: Parameter Calculation Error

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

  Patient problems: Laceration(s)

  MAUDE report 24233322 ↗
• MalfunctionFeb 2, 2026Application Program Problem: Parameter Calculation Error

  IT WAS REPORTED THAT, DURING A CORI ASSISTED UKR SURGERY USING ONE (1) REAL INTELLIGENCE CORI, AFTER COMPLETING ALL CUTS WITH THE BUR, SURGEON NOTED THAT THE FEMUR LUG HOLES WERE VERY MEDIAL. LOOKING AT THE PLAN, THE MODEL LOOKED MORE CENTERED THAN HOW MEDIAL THE LUGS LOOKED ON THE BONE. THE SURGEON'S DISTAL LANDMARK LOOKED VERY LATERAL BUT SHOULD BE THERE CENTER WITH HOW MEDIAL THE LUGS WERE. SURGEON ADJUSTED SIZE AND USED REAL THROUGH TRIALS TO CORRECT PEG HOLE POSITION. IT DOES NOT APPEAR THAT TRACKER MOVED AS THE ROM AND FINAL NUMBERS LOOKED LIKE PLAN. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE (MANUAL PROCEDURE). NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24231059 ↗
• MalfunctionJan 30, 2026Erratic or Intermittent Display; Connection Problem

  IT WAS REPORTED THAT, DURING A REAL INTELLIGENCE CORI ASSISTED TKA SURGERY, DURING THE FEMUR BONE REMOVAL, THE CORI SCREEN WENT BLACK FOR FEW SECONDS, AFTER RETURN OF THE SCREEN AN ERROR MESSAGE APPEARED ON SCREEN ABOUT DRILL DEACTIVATED. AFTER 3 UNSUCCESSFUL ATTEMPTS TO REINITIALIZE THE DRILL, ANOTHER BACK UP DRILL HAVE BEEN USED WITH THE SAME RESULT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH MANUAL PROCEDURE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24221513 ↗
• MalfunctionJan 29, 2026Application Program Problem: Parameter Calculation Error

  IT WAS REPORTED THAT, DURING A CORI ASSISTED TKA SURGERY USING ONE (1) REAL INTELLIGENCE CORI, AFTER PREPPING FEMUR DISTAL BUR PUNCH SIZE 9 5IN CUTTING GUIDE, THE SURGEON WENT TO BUR ALL AND FELT THAT THE BUR CUT TOO DEEP ON THE ANTERIOR CHAMFER CUT. SURGEON DOWNSIZED TO 8 AND FINISHED THE CUTS WITH MANUAL BLOCK. THE SURGEON WAS HAPPY WITH X-RAYS. TRACKING ARRAYS DID NOT MOVE. ADDITIONAL ANESTHESIA WAS NOT NECESSARY. THE PROCEDURE WAS RESUME, AFTER A NON-SIGNIFICANT DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE (MANUAL PROCEDURE). NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Laceration(s)

  MAUDE report 24215458 ↗
• MalfunctionJan 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IN LITERATURE REVIEW ¿LEARNING CURVES OF TWO SURGICAL ROBOT SYSTEMS FOR ASSISTED TOTAL KNEE ARTHROPLASTY AND THEIR IMPACT ON EARLY PATIENT CLINICAL OUTCOMES: A RETROSPECTIVE STUDY", DURING ONE (1) PRIMARY ROBOTIC-ASSISTED TKA SURGERY WITH CORI SYSTEM TO TREAT OSTEOARTHRITIS; THE SURGEON REQUIRED A CONVERSION TO CONVENTIONAL MANUAL TECHNIQUE DUE TO A FLEXION VALGUS DEFORMITY (20° FLEXION, 30° VALGUS). NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24210836 ↗
• MalfunctionJan 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IN LITERATURE REVIEW ¿LEARNING CURVES OF TWO SURGICAL ROBOT SYSTEMS FOR ASSISTED TOTAL KNEE ARTHROPLASTY AND THEIR IMPACT ON EARLY PATIENT CLINICAL OUTCOMES: A RETROSPECTIVE STUDY", DURING ONE (1) PRIMARY ROBOTIC-ASSISTED TKA SURGERY WITH CORI SYSTEM TO TREAT OSTEOARTHRITIS; THE SURGEON REQUIRED A CONVERSION TO CONVENTIONAL MANUAL TECHNIQUE DUE TO A STIFF KNEE (RANGE OF MOTION 10°-70°). NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24210795 ↗