REAL INTELLIGENCE ROB10035Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00885556757505), received between Nov 13, 2020 and Apr 28, 2026 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2026Mechanical Jam

  IT WAS REPORTED THAT, DURING CORI ASSISTED TKA SURGERY, WHILE DRILL CONNECTING, THE REAL INTELLIGENCE 5 MM CYLINDRICAL BU COULD NOT BE REMOVED FROM THE REAL INTELLIGENCE ROBOTIC DRILL. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, WITH CHANGE IN SURGICAL TECHNIQUE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25016593 ↗
• MalfunctionNov 1, 2024Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT, DURING A CORI ASSISTED TKA SURGERY, ONE (1) REAL INTELLIGENCE 5 MM CYLINDRICAL BU POPPED OUT RIGHT BEFORE BURRING AND WOULD NOT SEAT PROPERLY. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A S+N BACKUP DEVICE. NO INJURY WAS REPORTED AS A RESULT OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20588586 ↗
• InjuryApr 25, 2023Failure to Calibrate; Failure to Calibrate

  IT WAS REPORTED THAT, WHILE SETTING-UP FOR A CORI-ASSISTED TKA, UPON DRILL CALIBRATION, THE FOLLOWING MESSAGE KEPT APPEARING: "CALIBRATION VERIFICATION ERROR: FAILED TO VERIFY THE ROBOTIC DRILL CALIBRATION". A COMBINATION OF THREE DIFFERENT DRILLS, POINT PROBES, DRILL ATTACHMENTS AND LONG ATTACHMENTS WERE TRIED FROM ALL THREE CORI INSTRUMENT SETS, AS WELL AS DELETING AND ENTERING NEW CASE. IN ADDITION, THE CORI CONSOLE WAS SHUT DOWN AND TURNED BACK ON. HOWEVER, THE ERROR PERSISTED. SURGERY WAS PERFORMED, WITHOUT DELAY, BY MANUAL PROCEDURE INSTEAD. AFTER THE PROCEDURE WAS COMPLETED, CALIBRATION WAS SUCCESSFUL BY USING A DIFFERENT BURR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16808185 ↗
• MalfunctionOct 1, 2021Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT, DURING SET UP FOR A CORI ASSISTED SURGERY, THEY WERE OPENING THE REAL INTELLIGENCE 5 MM CYLINDRICAL BUR, WHEN THEY TOOK IT OUT OF THE STERILE PACK THE LID OF THE TUBE SLID OFF AND THE BURR FELL ON THE GROUND. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE WITHOUT SIGNIFICANT DELAY. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12565275 ↗
• InjuryNov 13, 2020Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING CORI TKA PROCEDURE WHILE BURRING ALL UNDER EXPOSURE MODE ON THE TIBIA IN AN XR CASE, SURGEON COMPLAINED THAT THE BUR "SKIPPED INTO SOFT TISSUE. IT IS UNKNOWN HOW WAS THE PROCEDURE COMPLETED.

  Patient problems: Injury; Unspecified Tissue Injury

  MAUDE report 10835428 ↗
• InjuryNov 13, 2020Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING CORI TKA PROCEDURE WHILE BURRING ALL UNDER EXPOSURE MODE ON THE TIBIA IN AN XR CASE, SURGEON COMPLAINED THAT THE BUR "SKIPPED" INTO THE FINISHED FEMORAL CONDYLE, TAKING OUT A CHUNK OF BONE. THE SURGEON DID NOT NOTE IF THIS CAUSED INJURY, OR IF IT WAS OUTSIDE THE CHAMFER CUT. THE FEMUR IMPLANT WAS SUCCESSFULLY CEMENTED.

  Patient problems: Injury; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10835420 ↗