Midas Rex® EM200-RRecalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00613994422002), received between May 5, 2017 and Apr 28, 2025 — classified as 3 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (19 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2025Difficult to Insert; Detachment of Device or Device Component; Difficult to Insert; Detachment of Device or Device Component

  IT WAS REPORTED THAT TWO MOTORS AT THE SITE WERE EXPERIENCING ISSUES. THE FIRST MOTOR COULD NOT HOLD THE ATTACHMENT SECURE, AND THAT THEY WOULD EVENTUALLY FALL OFF. THE SECOND MOTOR OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21916709 ↗
• MalfunctionMar 21, 2025Overheating of Device; Overheating of Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21661219 ↗
• MalfunctionMar 5, 2025Overheating of Device; Overheating of Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21523717 ↗
• MalfunctionMar 4, 2025Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR THE DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. REPAIR IS BEING ESCALATED TO PRODUCT EVENT DUE TO REASON FOR THE RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21512723 ↗
• MalfunctionFeb 6, 2025Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH REPORT OF OVERHEATING AND VIBRATING. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT DUE REASON FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21324202 ↗
• MalfunctionSep 18, 2024Difficult to Insert; Overheating of Device; Difficult to Insert; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF DIFFICULTY WITH ASSEMBLY. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT. REPAIR REQUEST ESCALATED TO PRODUCT EVENT DUE TO RETURN IN LESS THAN 90 DAYS FROM PURCHASE OR REPAIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20244203 ↗
• InjuryApr 3, 2020Overheating of Device; Loss of Power; Device Displays Incorrect Message; Overheating of Device; Loss of Power; Device Displays Incorrect Message

  IT WAS REPORTED THAT A PERFORATOR WAS USED TOGETHER WITH AN AD03 AND EM200-R DURING A BRAIN TUMOR RESECTION PROCEDURE. THEY NOTICED THAT THE NUMBER OF ROTATIONS ONLY REACHED ABOUT 4000 AND AN ERROR CODE 16 WAS DISPLAYED. AT THAT TIME, OVERHEATING ALSO OCCURRED. THERE WAS NO BACKUP DRILL THAT COULD BE USED AND THE PROCEDURE WAS DISCONTINUED FOR 90 MINUTES. DURING THAT TIME, A NON-MEDTRONIC DRILL WAS BORROWED FROM A DIFFERENT FACILITY TO COMPLETE THE PROCEDURE. ON FOLLOW UP, IT WAS REPORTED THAT THE PERFORATOR USED WAS A CODMAN AND IT WAS DISCARDED. IT WAS ALSO ADDED THAT THE PATIENT HAD NO FURTHER ISSUES POST-SURGERY.

  Patient problems: Chemical Exposure

  MAUDE report 9920551 ↗
• MalfunctionMar 10, 2020Overheating of Device; Overheating of Device

  ON FOLLOW-UP, NO FURTHER INFORMATION CAN BE PROVIDED REGARDING THE PATIENT STATUS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9814116 ↗
• MalfunctionAug 16, 2019Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT BASED ON REASON FOR RETURN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8903908 ↗
• MalfunctionMay 28, 2019Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH NO REPORTED MALFUNCTION. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT. REPAIR ESCALATED TO PRODUCT EVENT ON EVALUATION DUE TO OVERHEATING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8647468 ↗
• InjuryNov 19, 2018Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE DEVICE HAD A MALFUNCTION AND OVERHEATED. THE DOCTOR WAS USING THE PERFORATOR AND HE WAS HOLDING IT WHEN HE FELT THAT IT WAS GETTING HOT. ON FOLLOW-UP, IT WAS CONFIRMED THAT THE MOTOR OVERHEATED AND THAT THE DOCTOR HAD A BURN ON HIS THUMB (WHITE PATCH ON SKIN). THERE WAS A 5-7 MINUTES PROCEDURE DELAY DUE TO DEVICE REPLACEMENT AND PREPARATION. THERE WAS NO PATIENT IMPACT AND NO MEDICAL INTERVENTION DONE DUE TO THE INJURY.

  Patient problems: Burn(s)

  MAUDE report 8083908 ↗
• InjuryOct 24, 2018Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE DRILL OVERHEATED DURING USE. THE TEAM CHANGED THE ATTACHMENT BUT THE PROBLEM RE-OCCURRED. A NURSE BURNED HER HAND WHILE TRYING TO DISASSEMBLE THE ATTACHMENT FROM THE DRILL. NO PATIENT IMPACT REPORTED. ON FOLLOW-UP IT WAS CONFIRMED THAT NO ADDITIONAL ACTIONS WERE TAKEN BY THE NURSE TO RESOLVE INJURY.

  Patient problems: Burn(s)

  MAUDE report 8002019 ↗
• MalfunctionAug 9, 2018Overheating of Device; No Apparent Adverse Event; Overheating of Device; No Apparent Adverse Event

  REPAIR REQUEST INITIATED FOR DEVICE WITH NO REPORTED MALFUNCTION. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT. REPAIR ESCALATED TO PRODUCT EVENT DUE TO INFORMATION RECEIVED WITH THE DEVICE INDICATING THAT THE DEVICE OVERHEATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7768559 ↗
• MalfunctionMay 17, 2018Overheating of Device; Device Operates Differently Than Expected; Overheating of Device; Device Operates Differently Than Expected

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT BASED ON REASON FOR RETURN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7521567 ↗
• MalfunctionSep 5, 2017Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT BASED ON REASON FOR RETURN. ON FOLLOW UP IT WAS REPORTED THE PATIENT WAS FINE WITH NO FOLLOW UP REQUIRED. IT WAS CONFIRMED THE DEVICE OVERHEATED DURING THE CASE, HOWEVER, A BACK-UP DEVICE WAS USED WITH NO DELAY IN THE SPINAL PROCEDURE. THE EVENT DATE WAS PROVIDED AS WELL AS SURGEON AND INITIAL REPORTER CONTACT INFORMATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6843678 ↗
• MalfunctionAug 15, 2017Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT AND NO DELAY TO THE PROCEDURE. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT BASED ON REASON FOR RETURN. ON FOLLOW UP, IT WAS REPORTED THE EVENT DATE WAS UNKNOWN. THE OVERHEATING OCCURRED DURING A SPINAL SURGICAL PROCEDURE. A BACK UP DEVICE WAS USED WITH NO DELAY IN THE PROCEDURE. PATIENT INFORMATION WAS REQUESTED, HOWEVER NO INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6796011 ↗
• MalfunctionJun 28, 2017Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT. REPAIR REQUEST ESCALATED TO PRODUCT EVENT BASED UPON REASON FOR RETURN. ON FOLLOW UP, IT WAS REPORTED THAT THE MOTOR HEATED UP PRIOR TO THE PROCEDURE. IT WAS CONFIRMED THERE WAS NO IMPACT TO THE PATIENT. IN ADDITION, THE MODEL OF THE ATTACHMENT THAT WAS USED WITH THE MOTOR WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6672667 ↗
• MalfunctionMay 19, 2017Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT AND NO DELAY IN THE CASE. REPAIR REQUEST ESCALATED TO PRODUCT EVENT BASED UPON REASON FOR RETURN. ON FOLLOW UP THE FACILITY COULD NOT PROVIDE ANY ADDITIONAL INFORMATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6579025 ↗
• MalfunctionMay 11, 2017Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT DUE TO OVERHEATING OVER THRESHOLD. ON FOLLOW UP IT WAS REPORTED THE EVENT OCCURRED DURING AN ENT PROCEDURE AND NO ADDITIONAL NON-ROUTINE ACTIONS WERE TAKEN DUE TO THE OVERHEATING. A BACK UP DEVICE WAS USED WITH NO DELAY IN THE PROCEDURE. IT WAS CONFIRMED THERE WAS NO IMPACT. NO ADDITIONAL INFORMATION REGARDING THE PATIENT OR ATTACHMENT USED WITH THE MOTOR WAS PROVIDED. INITIAL REPORTER INFORMATION WAS PROVIDED AS WELL AS EVENT DATE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6561670 ↗
• MalfunctionMay 5, 2017Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT BASED ON OVERHEATING OVER THRESHOLD. ON FOLLOW UP WITH THE SALES REPRESENTATIVE THE OVERHEATING WAS IDENTIFIED DURING A ROUTINE PREVENTATIVE MAINTENANCE VISIT. THE SALES REPRESENTATIVE WAS TESTING MOTORS AT THE HOSPITAL, AND NOTED THE OVERHEATING. THERE WAS NO PATIENT OR PHYSICIAN INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 6549758 ↗