Midas Rex MR8 EM810 (UDI 00643169912113)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00643169912113), received between Dec 13, 2024 and Nov 23, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (5 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 23, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING THE E1 CRANIOTOMY PROCEDURE, THE MOTOR AND THE ATTACHMENT OVERHEATED, RESULTING IN A HEAT BLISTER ON THE SURGEON¿S HAND THROUGH TWO PAIRS OF SURGICAL GLOVES. IT WAS ALSO REPORTED THAT DUE TO THE CRITICAL NATURE AND URGENCY OF THE CASE, CHANGING OUT DRILLS WAS NOT AN OPTION AT THE TIME. ON ADDITIONAL INFORMATION THERE WAS NO PATIENT OR STAFF IMPACT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23627411 ↗
• MalfunctionMar 7, 2025Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21549549 ↗
• MalfunctionFeb 20, 2025Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21418410 ↗
• MalfunctionFeb 7, 2025Loss of Power; Device Displays Incorrect Message; Loss of Power; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING A CRANIOPLASTY FOR CRANIAL VAULT RECONSTRUCTION PROCEDURE, BOTH EM810S WERE WANTING TO BE USED AS JUST A FOOT CONTROL DRILL AND IPC READ ERROR CODE 18- WANTING FINGER LEVER TO BE RESEATED. DOCTORS DID NOT WANT TO USE FINGER LEVER. IPC WAS MARKED FOR ¿FOOT¿. WHEN FOOT PEDAL WAS ENGAGED, IPC WOULD JUMP FROM FINGER/FOOT AND SAFE/ ON AND DRILL BIT WOULD ONLY SPIN INTERMITTENTLY AND THEN GIVE ERROR CODE. WE PLACED A FINGER LEVER ON DRILL AND DOCS USED AS FOOT CONTROL WITH LEVER ON. ERROR CODE CONTINUED TO COME UP BUT DRILL WOULD WORK AFTER PRESSING OK. NO PATIENT IMPACT REPORTED. IT WAS ALSO REPORTED THAT THERE WAS AN INTERVENTION PERFORMED, NO DAMAGED PIECE REMAINED IN THE PATIENT'S BODY, AND THERE WAS 30 MINS DELAY IN PROCEDURE. THE PROCEDURE WAS COMPLETED WITH REPORTED PRODUCT AND THE PATIENT WAS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21330154 ↗
• MalfunctionFeb 7, 2025Loss of Power; Device Displays Incorrect Message; Loss of Power; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING A CRANIOPLASTY FOR CRANIAL VAULT RECONSTRUCTION PROCEDURE, BOTH EM810S WERE WANTING TO BE USED AS JUST A FOOT CONTROL DRILL AND IPC READ ERROR CODE 18- WANTING FINGER LEVER TO BE RESEATED. DOCTORS DID NOT WANT TO USE FINGER LEVER. IPC WAS MARKED FOR ¿FOOT¿. WHEN FOOT PEDAL WAS ENGAGED, IPC WOULD JUMP FROM FINGER/FOOT AND SAFE/ ON AND DRILL BIT WOULD ONLY SPIN INTERMITTENTLY AND THEN GIVE ERROR CODE. WE PLACED A FINGER LEVER ON DRILL AND DOCS USED AS FOOT CONTROL WITH LEVER ON. ERROR CODE CONTINUED TO COME UP BUT DRILL WOULD WORK AFTER PRESSING OK. NO PATIENT IMPACT REPORTED. IT WAS ALSO REPORTED THAT THERE WAS AN INTERVENTION PERFORMED, NO DAMAGED PIECE REMAINED IN THE PATIENT'S BODY, AND THERE WAS 30 MINS DELAY IN PROCEDURE. THE PROCEDURE WAS COMPLETED WITH REPORTED PRODUCT(S).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21330127 ↗
• MalfunctionJan 10, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE LEARNED THAT THE HOSPITAL HAD THIS ELECTRIC MOTOR SET ASIDE FOR REPAIR ON THIS DATE - 12/16/2024 WHEN I WENT TO SEE THE SUPPLY COORDINATOR ABOUT A DIFFERENT MOTOR ISSUE AND IT WAS SET ASIDE IN A BOX. IT HAD A LABEL ON IT SAYING "MOTOR OVERHEATING". I SENT AN EMAIL TO THE CRN REQUESTING MORE DETAILS BUT WHAT THE SUPPLY STAFF ADVISE IS THAT IT OVER HEATED AND THERE WERE NO ISSUES TO PATIENT AND A DIFFERENT MOTOR WAS USED IN SURGERY. I WILL ADD ANY MORE INFORMATION I RECEIVE FROM THE CRN ONCE JODI BROACH RESPONDS. THERE WAS NO PATIENT INVOLVED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21124380 ↗
• MalfunctionDec 13, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE ELECTRIC MOTOR AND CORD WERE HEATING UP AND ANOTHER ELECTRIC MOTOR WAS USED TO SOLVE THE PROBLEM. THIS CONTINUED TO OCCUR EVEN AFTER ASSEMBLY VERIFIED TO BE CORRECT. IN ADDITION THE DRILL WAS TESTED AND TRIED WITH A DIFFERENT ATTACHMENT AND THAT DID NOT RESOLVE THE PROBLEM. THE MOTOR AND CORD WOULD HEAT UP AFTER A SHORT DURATION OF TIME AND THE DRILL WAS USED APPROPRIATELY. NOTHING HAPPENED TO THE PATIENT. THE SURGEON STOPPED USING THAT DRILL AND ONCE A NEW DRILL WAS USED THE ISSUE RESOLVED. THE DRILL HAS NOT BEEN SENT TO MEDTRONIC AS THEY FEEL ITS TO EXPENSIVE TO USE OUR SERVICE PLAN AND THEY ARE REVIEWING THEIR OPTIONS AT THIS TIME BUT THIS DRILL IS NOT IN CIRCULATION ANYMORE. THERE WAS NO PATIENT INVOLVED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20923045 ↗