Real Intelligence ROB10086Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556774878), received between Jun 10, 2022 and Oct 21, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Application Program Problem: Parameter Calculation Error” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 21, 2024Application Program Problem: Parameter Calculation Error; Application Program Problem: Parameter Calculation Error

  IT WAS REPORTED THAT, DURING A CORI ASSISTED TKA SURGERY, IT WAS NOTICED THAT THE REAL INTELLIGENCE PLANE VISUALIZER IS OFF. IT SHOWS THAT THE CUT GUIDE IS AT EXTERNAL ROTATION OF 2.5 MM. REPLACED WITH A DIFFERENT PLANE CHECKER AND SHOWED THAT THE CUT GUIDE DID NOT HAVE ANY EXTERNAL ROTATION. THE SURGERY WAS COMPLETED, AFTER A NON-SIGNIFICANT DELAY. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20493579 ↗
• MalfunctionJun 10, 2022Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT, DURING PREVENTATIVE MAINTENANCE, IT WAS NOTICED THAT THE REAL INTELLIGENCE PLANE VISUALIZER WON'T SLIDE ALL THE WAY ONTO THE POINT PROBE. IT WAS TESTED WITH DIFFERENT POINT PROBES TO CONFIRM AND IT WOULDN'T SLIDE ON EITHER. IT APPEARS THERE MIGHT BE A PIECE OF METAL THAT WASN¿T PROPERLY CUT WHEN YOU LOOK THROUGH THE OPENING OF THE PLANE VISUALIZER. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14659102 ↗