MIDAS REX MR8 MR8-AA12 (UDI 00763000440862)Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00763000440862), received between Aug 11, 2024 and Sep 30, 2026 — classified as 28 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Overheating of Device; Noise, Audible

  It was reported that during a spine procedure, the attachment made a noise while working and heated up. At the time of report, the patient was involved but was alive with no injury. Additional intervention of change of attachment was made and the procedure was completed with the backup product(s).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50942501 ↗
• MalfunctionSep 15, 2026No Apparent Adverse Event

  It was reported that the device was defective. It was reported that there was no patient involved. Additional information was received stating that detached bearings were found during evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50768125 ↗
• MalfunctionSep 10, 2026No Apparent Adverse Event

  Medtronic received information regarding a repair request, and no alleged product deficiencies were reported. It was reported that there was no patient impact. Additional information was received stating that detached bearings were found during evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50707219 ↗
• MalfunctionJul 2, 2026Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION REGARDING A REPAIR REQUEST AND NO ALLEGED PRODUCT DEFICIENCIES WERE REPORTED. AT THE TIME OF THE REPORT, THERE WAS NO KNOWN IMPACT TO THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION

  Patient problems: Insufficient Information

  MAUDE report 25686764 ↗
• MalfunctionJul 2, 2026No Apparent Adverse Event

  MEDTRONIC RECEIVED INFORMATION REGARDING A REPAIR REQUEST WITH NO ALLEGED PRODUCT DEFICIENCY. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION WAS RECEIVED STATING DISTAL BEARING IS BROKEN WAS FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25686680 ↗
• MalfunctionJun 26, 2026No Apparent Adverse Event

  MEDTRONIC RECEIVED INFORMATION REGARDING A REPAIR REQUEST, AND NO ALLEGED PRODUCT DEFICIENCIES WERE REPORTED. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION RECEIVED STATED THAT THE DISTAL BEARING IS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25644335 ↗
• MalfunctionJun 26, 2026Difficult to Insert

  IT WAS REPORTED THAT THE DEVICE WAS LOCKING MALFUNCTION. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25632646 ↗
• MalfunctionJun 23, 2026Overheating of Device

  IT WAS REPORTED THAT ATTACHMENT WAS GETTING HOT DURING INTRA OP. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25589389 ↗
• MalfunctionJun 16, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE AFTER USE A RING WAS RINSED OUT OF THE HANDPIECE DURING REPROCESSING. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25518698 ↗
• MalfunctionJun 11, 2026No Apparent Adverse Event

  MEDTRONIC RECEIVED INFORMATION REGARDING A REPAIR REQUEST AND NO ALLEGED PRODUCT DEFICIENCIES WERE REPORTED. THERE WAS NO PATIENT INVOLVED. ADDITIONAL INFORMATION WAS RECEIVED STATING BEARINGS INSIDE THE DEVICE WERE BROKEN DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25467016 ↗
• MalfunctionMay 26, 2026No Apparent Adverse Event

  MEDTRONIC RECEIVED INFORMATION REGARDING A REPAIR REQUEST, AND NO ALLEGED PRODUCT DEFICIENCIES WERE REPORTED. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED DISTAL BEARING WAS FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25278959 ↗
• MalfunctionMay 22, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THERE WAS GENERAL DISSATISFACTION. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25256355 ↗
• MalfunctionMay 20, 2026No Apparent Adverse Event

  MEDTRONIC RECEIVED INFORMATION REGARDING A REPAIR REQUEST AND NO ALLEGED PRODUCT DEFICIENCIES WERE REPORTED. NO PATIENT IMPACT REPORTED. ADDITIONAL INFORMATION RECEIVED AFTER PRODUCT EVALUATION THAT BEARING DETACHED AND BROKEN TOOL INSIDE THE ATTACHMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25227133 ↗
• MalfunctionApr 21, 2026Difficult to Insert

  IT WAS REPORTED THAT THE CUTTER CAN NO LONGER BE INSERTED DURING USE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24944974 ↗
• MalfunctionApr 16, 2026No Apparent Adverse Event

  MEDTRONIC RECEIVED INFORMATION REGARDING A REPAIR REQUEST AND NO ALLEGED PRODUCT DEFICIENCIES WERE REPORTED. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24892412 ↗
• MalfunctionApr 7, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT CUSTOMER HAD A DISSATISFACTION WITH THE ATTACHMENT. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT. ADDITIONAL INFORMATION RECEIVED STATING THAT TOP DISTAL BEARING IS DETACHED, FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24797219 ↗
• MalfunctionApr 2, 2026No Apparent Adverse Event

  MEDTRONIC RECEIVED INFORMATION REGARDING A REPAIR REQUEST, AND NO ALLEGED PRODUCT DEFICIENCIES WERE REPORTED. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARING WAS FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24761738 ↗
• MalfunctionJan 19, 2026No Apparent Adverse Event

  MEDTRONIC RECEIVED INFORMATION REGARDING A REPAIR REQUEST AND NO ALLEGED PRODUCT DEFICIENCIES WERE REPORTED. NO KNOWN PATIENT REPORTED. ADDITIONAL INFORMATION WAS RECEIVED STATING DETACHED BEARING WAS FOUND DURING EVALUATION.

  Patient problems: Insufficient Information

  MAUDE report 24108821 ↗
• MalfunctionDec 4, 2025No Apparent Adverse Event; No Apparent Adverse Event

  MEDTRONIC RECEIVED INFORMATION REGARDING A REPAIR REQUEST AND NO ALLEGED PRODUCT DEFICIENCIES WERE REPORTED. NO PATIENT IMPACT REPORTED. ADDITIONAL INFORMATION WAS RECEIVED STATING DISTAL BEARING DETACHMENT WAS FOUND DURING EVALUATION.

  Patient problems: Insufficient Information

  MAUDE report 23712550 ↗
• MalfunctionNov 20, 2025No Apparent Adverse Event; No Apparent Adverse Event

  MEDTRONIC RECEIVED INFORMATION REGARDING A REPAIR REQUEST AND NO ALLEGED PRODUCT DEFICIENCIES WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: Insufficient Information

  MAUDE report 23601528 ↗
• MalfunctionSep 3, 2025No Apparent Adverse Event; No Apparent Adverse Event

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF NO ALLEGATION. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. REPAIR ESCALATED TO PRODUCT EVENT ON EVALUATION DUE TO DETACHED BEARING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22952892 ↗
• MalfunctionJul 25, 2025Naturally Worn; Naturally Worn

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF WORN. NO PATIENT IMPACT REPORTED. REPAIR ESCALATED TO PRODUCT EVENT ON EVALUATION DUE TO DETACHED BEARING.

  Patient problems: Insufficient Information

  MAUDE report 22606733 ↗
• MalfunctionJul 14, 2025No Apparent Adverse Event; No Apparent Adverse Event

  THERE WAS NO ALLEGED ISSUE AT THE TIME OF INTAKE. NO PATIENT IMPACT WAS REPORTED. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT DUE TO EVALUATION FINDING OF DETACHED BEARING. ON FOLLOW-UP IT WAS REPORTED THAT THERE WERE NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22493233 ↗
• MalfunctionJun 30, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE ATTACHMENT IS NOT POSSIBLE TO ATTACH. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22354890 ↗
• MalfunctionJun 22, 2025No Apparent Adverse Event; No Apparent Adverse Event

  REPAIR REQUEST INITIATED FOR DEVICE WITH UNSPECIFIED MALFUNCTION. NO PATIENT IMPACT WAS REPORTED. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT DUE TO EVALUATION FINDING OF DETACHED BEARINGS.

  Patient problems: Insufficient Information

  MAUDE report 22304590 ↗