MIDAS REX MR8 MR8-AS10 (UDI 00763000441050)Recalls & reported problems

Summary

The FDA's MAUDE database contains 77 adverse event reports that list this exact device (DI 00763000441050), received between Aug 9, 2024 and Sep 23, 2026 — classified as 1 injury, 76 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (28 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 25 most recent of 77 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Detachment of Device or Device Component

  It was reported that the bearing parts came out of the unit. At the time of the report, there was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50865498 ↗
• MalfunctionJul 1, 2026Corroded

  IT WAS REPORTED THAT DURING SERVICING, RUST WAS IDENTIFIED IN THE ATTACHMENT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25680239 ↗
• MalfunctionJun 30, 2026Difficult to Insert; Naturally Worn

  IT WAS REPORTED THAT THE ATTACHMENT HAVE BEARING DAMAGE , DIFFICULT TO INSERT TOOLS. 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 25663564 ↗
• MalfunctionJun 29, 2026Vibration; Detachment of Device or Device Component

  IT WAS REPORTED THAT PRIOR TO USE, THE ATTACHMENT PARTS FELL OFF AND WOBBLES. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25649249 ↗
• MalfunctionJun 25, 2026Naturally Worn

  IT WAS REPORTED THAT THERE IS A BEARING PROBLEM. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25619378 ↗
• MalfunctionJun 25, 2026Difficult to Insert

  IT WAS REPORTED THAT ATTACHMENT WAS FAULTY AND DRILL KICKS BACK. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25617664 ↗
• MalfunctionJun 22, 2026Naturally Worn

  IT WAS REPORTED THAT THERE WERE BEARING ISSUES IN THE ATTACHMENT DURING TESTING. AT THE TIME OF REPORT, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25577547 ↗
• MalfunctionJun 21, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PRIOR TO THE PROCEDURE, DROPPED BEARING WAS OBSERVED. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25572148 ↗
• MalfunctionJun 21, 2026Vibration

  IT WAS REPORTED THAT THE DEVICE WAS JUMPING . IT WAS REPORTED THAT THERE IS 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 25571706 ↗
• MalfunctionJun 19, 2026Naturally Worn

  IT WAS REPORTED THAT THE ATTACHMENT WAS NOT WORKING PROPERLY. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT BROKEN  BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25561166 ↗
• MalfunctionJun 19, 2026Difficult to Insert; Difficult to Remove; Naturally Worn

  IT WAS REPORTED THAT IN ATTACHMENT  SOMETHING WAS STUCK INSIDE THE DEVICE AND THE BEARING WAS DAMAGED, AND THE BURR DID NOT TURN FREELY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25559664 ↗
• MalfunctionJun 19, 2026Loss of Power; Naturally Worn

  IT WAS REPORTED THAT THE ATTACHMENTS WAS NOT WORKING. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WERE BROKEN BEARINGS INSIDE THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25557446 ↗
• MalfunctionJun 19, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE ATTACHMENT WAS NOT WORKING PROPERLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED AFTER EVALUATION AS BROKEN BEARINGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25556828 ↗
• MalfunctionJun 18, 2026Naturally Worn

  IT WAS REPORTED THAT PRE-OPERATION THE BEARINGS WERE BAD/LOUD AND RUNNING ROUGH. AT THE TIME OF REPORT, THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25543852 ↗
• MalfunctionJun 18, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE ATTACHMENT WAS NOT WORKING PROPERLY. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DAMAGE BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25543700 ↗
• MalfunctionJun 18, 2026Naturally Worn

  IT WAS REPORTED THAT THE ATTACHMENT HAS BEARING PROBLEM. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DAMAGE BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25542699 ↗
• MalfunctionJun 18, 2026Noise, Audible

  IT WAS REPORTED THAT, DURING PRE-OPERATIVE PREPARATION FOR USE, THE ATTACHMENT EXHIBITED A NOISY SOUND. 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 25542387 ↗
• MalfunctionJun 17, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING PRE-OP, THE ATTACHMENT BEARINGS DISLODGED. 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 25530091 ↗
• MalfunctionJun 17, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE ATTACHMENT BEARINGS DROPPED. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25529705 ↗
• MalfunctionJun 17, 2026Naturally Worn

  IT WAS REPORTED THAT THE ATTACHMENT BEARING WAS FAULTY. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25529636 ↗
• MalfunctionJun 17, 2026Naturally Worn

  IT WAS REPORTED THAT THE DEVICE BEARING WAS PROBLEM PRIOR TO USE. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT BEARING BROKEN WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25528952 ↗
• MalfunctionJun 17, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DEVICE BEARING WAS DROPPED PRIOR TO USE. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25528784 ↗
• MalfunctionJun 17, 2026Vibration

  IT WAS REPORTED THAT THE ATTACHMENT HAD EXCESSIVE VIBRATION. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25528059 ↗
• MalfunctionJun 16, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE DEVICE WAS NOT WORKING PROPERLY. AT THE TIME OF REPORT, THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25521412 ↗
• MalfunctionJun 16, 2026Naturally Worn

  IT WAS REPORTED THAT DURING PRE-OP, ATTACHMENT BEARINGS BROKE. 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 25516932 ↗