REAL INTELLIGENCE ROB10014Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00885556757338), received between Oct 8, 2020 and Oct 1, 2024 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (7 reports).

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.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 1, 2024Break; Break

  IT WAS REPORTED THAT, DURING SETUP FOR CORI ASSISTED TKA PROCEDURE, A REAL INTELLIGENCE ROBOTIC DRILL TRACKER WAS BROKEN. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, BY CHANGING THE SURGICAL TECHNIQUE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20344373 ↗
• MalfunctionApr 11, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING CORI ASSISTED TKA SURGERY, THE ROBOTIC DRILL KEPT COMING IN AND OUT OF VIEW WITH THE CAMERA. THEY WIPED THE FLAT MARKERS OFF AND ENSURED THEY WERE SEATED, BUT STILL EXPERIENCED THE DRILL COMING IN AND OUT OF VIEW WITH THE CAMERA EVEN THOUGH IT WAS IN A DIRECT LINE OF SITE WITH THE CAMERA. UPON VISUAL INSPECTION, IT APPEARED THAT THE REAL INTELLIGENCE ROBOTIC DRILL TRACKER WAS BENT. PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14072119 ↗
• MalfunctionMar 8, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING SET UP FOR A CORI ASSISTED UKR SURGERY, THE REAL INTELLIGENCE ROBOTIC DRILL TRACKER WAS BENT ON ONE OF THE RECEIVERS THE FLAT MARKER GOES ON. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13694479 ↗
• MalfunctionJan 24, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT WHEN CHECKING TRAYS OF NEW SHIPMENT, THE REAL INTELLIGENCE ROBOTIC DRILL TRACKER WAS BENT AND UNABLE TO BE USED. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13339519 ↗
• MalfunctionJun 2, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING THE SET UP FOR A CORI LAB, THE REAL INTELLIGENCE ROBOTIC DRILL WAS ALREADY ASSEMBLED AND THE RI ROBOTIC DRILL ATTACHMENT WAS LOCKED ONTO THE DRILL AND WAS NOT ABLE TO REMOVE THE ATTACHMENT CASE (B)(4). THE REAL INTELLIGENCE ROBOTIC DRILL TRACKER HAD A BENT FLAT MARKER POINT CASE (B)(4). THE LAB WAS COMPLETED USING A S+N BACK-UP DEVICES. NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11921376 ↗
• MalfunctionMar 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING CORI LEGION CR TKA PROCEDURE, THEY PASSED DRILL DIAGNOSTICS PRIOR TO CASE CREATION AND THERE WERE NO ERRORS LEADING UP TO DISTAL FEMUR CUT. HOWEVER, WHEN ENTERED DISTAL FEMUR CUT SCREEN, BUR WAS NOT EXPOSING PAST THE GUARD ((B)(4)). ABOUT 7-10 SECONDS INTO THIS SCREEN, WITH NO BONE BEING CUT DUE TO LACK OF BUR EXPOSURE, A BAD CONSOLE ERROR POPS UP ON SCREEN ((B)(4)). THE PEAK PLASMA BLADE WAS IN USE DURING THIS CASE (AT 8 AND 6) THOUGH NOT ACTIVELY CAUTERIZING AT THE TIME OF THE DISTAL CUT. BEGAN TROUBLESHOOTING: INITIALLY EXITED CASE AND IMMEDIATELY RE-ENTERED, BUT THE 24 INCH TOUCHSCREEN WAS FLICKERING ((B)(4)), SO QUIT AND EXITED THE CASE AND COMPLETELY SHUT DOWN THE SYSTEM. UPON RESTART, RE-ENTERED CASE WITHOUT ISSUE. COMPLETED CASE THROUGH INITIAL POST-OP GAP ASSESSMENT WITH CORI, BUT THEN NEEDED TO RECUT TIBIA AND COULD NOT REPLACE CUT BLOCK WITH TIBIA ARRAY IN PLACE (COVERED ON (B)(4)), SO REMOVED ARRAY AND COMPLETED RE-CUT AND RE-TRIALING MANUALLY. DELAY REPORTED OF FEWER THAN 30 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11580333 ↗
• MalfunctionDec 2, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CORI PREVENTIVE MAINTENANCE, IT WAS FOUND THAT THE ATTACHMENT FOR THE FLAT MARKERS FROM THE DRILL TRACKER ARRAY WAS BENT. NO PATIENT WAS INVOLVED. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10934487 ↗
• MalfunctionDec 2, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING CORI PREVENTIVE MAINTENANCE, IT WAS FOUND THAT THE DRILL ARRAY'S ATTACHMENT FOR FLAT MARKERS WAS BENT. NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10934390 ↗
• InjuryOct 8, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING A CORI PROCEDURE, THEY USED BOTH THE SIDE AND THE END OF THE BUR IN SPEED CONTROL TO REFINE THE SURFACE OF THE BONE. THERE WAS A DISCREPANCY VISIBLE ON THE ORDER OF 1 TO 2 MM BETWEEN THE BONE SURFACE REFINED WITH THE SIDE OF THE BUR RELATIVE TO THE REGISTERED POSITION OF THE TIP OF THE BUR. (WHEN HE PLACED THE TIP OF THE BUR ON THE BONE SURFACE WHERE HE'D JUST REFINED, THE TIP HOVERED OVER THE REFINED SURFACE BY 1-2MM. THE POINTER PROBE WAS USED TO CHECK THE SURFACE, AND THE POINTER PROBE TIP AGREED WITH THE HANDPIECE TIP LOCATION. THE DOCTOR USED A SAW TO CUT MOST OF THE MEDIAL SIDE OF THE JOINT, AND DID NOT SEEM TO FINISH THE LATERAL SIDE. THE PLATE PROBE WAS USED TO VERIFY THE CUT, WHICH REGISTERED A 2 DEGREE VARUS CUT RELATIVE TO PLAN, WHICH WOULD BE CONSISTENT WITH THE FINAL COLORING OF THE SURFACE. THIS ALSO TENDS TO AGREE WITH THE FINAL REGISTERED LEG ALIGNMENT, WHICH WAS 6 DEGREES, AS OPPOSED TO A PLANNED 3 DEGREES OF VARUS. THE DOCTOR STATED THAT THE 6 DEGREE REPORTED ALIGNMENT "LOOKS LIKE 3 DEGREES"). IT WAS DIFFICULT TO KNOW HOW MUCH OF THE "RED" ON THE MEDIAL CONDYLE WAS A CONTRIBUTOR TO THE VARUS CUT ERROR, OR IF IT WAS SIMPLY A "VIRTUAL OV

  Patient problems: Injury

  MAUDE report 10652771 ↗