Midas Rex AD03Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00763000084707), received between Aug 16, 2019 and Jun 18, 2026 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (4 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.

• MalfunctionJun 18, 2026Difficult to Remove

  IT WAS REPORTED THAT TIGHTNESS WAS OBSERVED WITH THE DRIVE SHAFT, OUTPUT DURING PRE-OPERATIVE PREPARATION FOR USE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25542826 ↗
• MalfunctionJun 8, 2026Naturally Worn

  IT WAS REPORTED THAT THE THERE'S AN ABNORMAL ROUGH SOUND DURING USAGE. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25424930 ↗
• MalfunctionAug 13, 2025Overheating of Device; Naturally Worn; Overheating of Device; Naturally Worn

  IT WAS REPORTED THAT THE DEVICE HAS A BEARING PROBLEM, WHEN PUT INTO OPERATION, THE HANDPIECE OVERHEATS. THERE WAS NO PATIENT INVOLVED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22792132 ↗
• MalfunctionAug 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF LOCK NOTCH COMING OUT. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22712895 ↗
• 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 21424168 ↗
• MalfunctionFeb 18, 2025Overheating of Device; Physical Resistance/Sticking; Overheating of Device; Physical Resistance/Sticking

  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 21394714 ↗
• MalfunctionFeb 18, 2025Overheating of Device; Smoking; Noise, Audible; Overheating of Device; Smoking; Noise, Audible

  IT WAS REPORTED THAT DURING CRANIOTOMY WHEN THE SURGEON ENGAGED THE MIDAS REX DRILL. THE DRILL IMMEDIATELY STARTED TO SMOKE. THE HANDPIECE WAS OVERHEATING AND NOISY. THE DRILL WAS TAKEN OFF THE FIELD WITHOUT ANY OTHER INCIDENT. ADDITIONAL INFORMATION REGARDING THE PATIENT IMPACT WAS BEING FOLLOWED UP FROM THE FACILITY. ON FOLLOW UP IT WAS REPORTED THAT THERE WAS A DELAY OF 10 MIN IN SURGICAL PROCEDURE AS A RESULT OF THIS EVENT AND THERE WAS NO PATIENT OR STAFF IMPACT AS A RESULT OF THIS EVENT. NO ADDITIONAL INTERVENTIONS WERE TAKEN TO PREVENT IMPACT OR INJURY IN ASSOCIATION WITH THIS DEVICE PRIOR TO RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21393548 ↗
• InjuryAug 20, 2020Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING A CRANIOTOMY PROCEDURE, A NON-MEDTRONIC CODMAN (INTEGRA) PERFORATOR WAS USED WITH A MEDTRONIC EM100-A AND AN AD03 AND IT WAS REPORTED THAT IT DID NOT STOP WHICH CAUSED MENINGEAL BLEEDING. ON FOLLOW-UP, NO FURTHER INFORMATION CAN BE PROVIDED REGARDING THE EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 10434306 ↗
• InjuryAug 16, 2019Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING A CRANIOTOMY CASE, AN AD03 WAS USED WITH A NON-MDT DEVICE AND THE TOOL GOT STUCK IN THE PATIENT'S HEAD. THE TOOL WAS IDENTIFIED TO BE A CODMAN DEVICE AND WAS REMOVED FROM THE PATIENT. IT WAS CONFIRMED THAT THE PATIENT DID NOT REQUIRE ANY ADDITIONAL NON-ROUTINE INTERVENTIONS. IT WAS ALSO REPORTED THAT THE AD03 WAS FUNCTIONING PROPERLY AND IS NOT SUSPECTED TO CAUSE THE INJURY AT THIS TIME. THE AD03 IS BEING HELD BY THE HOSPITAL'S RISK MANAGEMENT DEPARTMENT AND WILL NOT BE RETURNED AT THIS TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 8903927 ↗