MIDAS REX MR8 MR8-F2/7TA23 (UDI 00763000513412)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00763000513412), received between Dec 3, 2024 and Aug 27, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Fracture” (5 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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2026Difficult to Remove

  It was reported that the blade was stuck in the nose of the attachment. At the time of report, there was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50470576 ↗
• MalfunctionMay 29, 2026Fracture

  IT WAS REPORTED THAT DURING CRANIOTOMY THE PART OF THE DRILL BIT THAT ATTACHES TO THE DRILL MOTOR'S COLLAR BROKE OFF AND WAS LOST. THIS CAUSED DELAY OF 20 TO 30 MINUTES IN THE PROCEDURE, SURGERY WAS COMPLETED WITH BACKUP PRODUCT. AT THE TIME OF THE REPORT, IMPACT TO THE PATIENT WAS UNKNOWN. ADDITIONAL INFORMATION RECEIVED STATING THAT THE THERE WAS NO IMPACT TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25329329 ↗
• MalfunctionDec 2, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A CRANIOTOMY PROCEDURE WITH A TAPERED TOOL AND ATTACHMENT, THE TOOL TIP BROKE OFF. ACCORDING TO SURGEON THERE IS NO SUSPICION OF TOOL MALFUNCTION. THE SURGEON ALSO STATED THAT TOOL TIP BROKE OFF AS A RESULT OF EXCESS POWER AND MANIPULATION DUE TO THE PATIENT´S BONE THICKNESS. NO PATIENT IMPACT REPORTED. THE PROCEDURE WAS COMPLETED WITH THE BACKUP PRODUCT. ON ADDITIONAL FOLLOW-UP, IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23693568 ↗
• MalfunctionMay 29, 2025Fracture; Fracture

  REPAIR REQUEST INITIATED FOR DEVICE WITH NO REPORTED MALFUNCTION. NO PATIENT IMPACT REPORTED. REPAIR ESCALATED TO PRODUCT EVENT ON EVALUATION DUE TO DETACHED BEARING AND BROKEN TOOL.

  Patient problems: Insufficient Information

  MAUDE report 22103949 ↗
• MalfunctionApr 30, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING CRANIOTOMY SURGERY WHEN USING THE TOOL THE HEAD IS BROKEN, THE TOOL TIP THAT WAS LEFT ON THE BONE BOARD IS REMOVED. NO PATIENT IMPACT REPORTED. IT WAS REPORTED THAT THERE WERE NO FRAGMENTS LEFT INSIDE THE PATIENT AND THERE WAS NO DELAY IN PROCEDURE AS  A RESULT OF THE EVENT. THE PROCEDURE WAS COMPLETED WITH THE BACKUP PRODUCT. NO ADDITIONAL INTERVENTION WAS PERFORMED OR PLANNED AS A RESULT OF THIS EVENT. ON FOLLOW UP, IT WAS CONFIRMED WITH THE HEALTH CARE PROFESSIONAL THAT THERE WAS NO PATIENT OR STAFF IMPACT  .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21933486 ↗
• MalfunctionApr 8, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING THE CRANIOTOMY PROCEDURE, THE DRILL BIT OVERHEATED AT STOLLERY. NO PATIENT IMPACT REPORTED. ON FOLLOW-UP IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT, THERE WAS A SLIGHT DELAY, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DRILL.

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

  MAUDE report 21794312 ↗
• MalfunctionDec 3, 2024Fracture; Fracture

  ON FOLLOW UP IT WAS CONFIRMED THAT THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20834152 ↗