MIDAS REX MR8 MR8-AA10DKRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00763000440855), received between Sep 17, 2024 and Jun 24, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (7 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 24, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING PRE-OP A DROPPED BEARING WAS OBSERVED IN THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25604507 ↗
• MalfunctionJun 18, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT PRIOR TO USE, ATTACHMENT HAD BEARING DROPPED. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25542415 ↗
• MalfunctionJun 17, 2026Overheating of Device

  IT WAS REPORTED THAT THE ATTACHMENT WAS OVERHEATING PRIOR TO USE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT BEARING FALL OUT WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25529784 ↗
• MalfunctionJun 17, 2026Naturally Worn

  IT WAS REPORTED THAT THE ATTACHMENT HAD A NOISY BEARING. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25528146 ↗
• MalfunctionJun 5, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT PRIOR TO USE, BEARING DISLODGED. AT THE TIME OF REPORT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25403297 ↗
• MalfunctionSep 2, 2025Vibration; Detachment of Device or Device Component; Vibration; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING MICROVASCULAR DECOMPRESSION SURGEON DESCRIBED SOME CHATTERING OF THE BURR AND THE BALL BEARINGS AND RINGS FELL OUT OF THE ATTACHMENT. NO PATIENT IMPACT REPORTED. IT WAS ALSO REPORTED THAT THE SURGICAL TEAM CHANGED THE ATTACHMENT FOR A NEW ONE AND THE CASE CONTINUED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22932098 ↗
• MalfunctionJun 20, 2025Vibration; Detachment of Device or Device Component; Vibration; Detachment of Device or Device Component

  IT WAS REPORTED THAT THAT DURING SPINAL DECOMPRESSION PROCEDURE THE ATTACHMENT WAS DISPLAYING EXCESSIVE VIBRATION AND WHEN THE TOOL WAS REMOVED A METAL RING CAME OUT FROM ATTACHMENT. NO PATIENT IMPACT REPORTED. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. ADD ITIONAL INFORMATION REGARDING THE PATIENT IMPACT WAS BEING FOLLOWED UP FROM THE FACILITY. ON ADDITIONAL FOLLOW UP THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22296086 ↗
• MalfunctionMay 7, 2025Vibration; Detachment of Device or Device Component; Vibration; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE SPINAL DECOMPRESSION PROCEDURE, SURGEON NOTED EXCESSIVE VIBRATION AND CHATTER DURING A SPINAL DECOMPRESSION PROCEDURE. WHEN THE ATTACHMENT WAS REMOVED IT WAS NOTED THAT THE DISTAL BEARING WAS DISLODGED AND STILL SITTING ON THE SHAFT OF THE DISSECTION TOOL. NO PATIENT IMPACT REPORTED. IT WAS ALSO REPORTED THAT THERE WAS NO INTERVENTION PERFORMED, NO DAMAGED PIECE REMAINED IN THE PATIENT'S BODY, AND THERE WAS NO DELAY IN PROCEDURE. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT(S). ON FOLLOW-UP IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21975347 ↗
• MalfunctionMar 7, 2025Overheating of Device; Vibration; Naturally Worn; Overheating of Device; Vibration; Naturally Worn

  IT WAS REPORTED THAT DURING A PROCEDURE, DRILL WAS DESCRIBED AS SHUDDERING OR JUMPING WHEN APPLIED TO BONE. APPEARS TO BE A DISTAL B EARING ISSUE AS HAS BEEN PREVIOUSLY NOTED AT THIS SITE. THIS ATTACHMENT WAS A WARRANTY REPLACEMENT FOR A PREVIOUS INCIDENT. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT. IT WAS ALSO REPORTED THAT THERE WAS NO INTERVENTION PERFORMED, NO DAMAGED PIECE REMAINED IN THE PATIENT'S BODY, AND THERE WAS NO DELAY IN PROCEDURE. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT(S). ON FURTHER INFORMATION IT WAS STATED AS DEVICE OVERHEATING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21543766 ↗
• MalfunctionSep 17, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF BEARING DETACHMENT. IT WAS REPORTED 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 20234401 ↗