MIDAS REX MR8 MR8-T14BA40DRecalls & reported problems
Medtronic Powered Surgical Solutions · TOOL MR8-T14BA40D MR8 14CM TLS BAL D 4MM · Class 2
All models of MIDAS REX MR8 (137)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000514303), received between Dec 30, 2025 and Mar 13, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Fracture” (3 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.
Reports received per month
Most reported problems
Device problems
- Fracture3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information2
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 13, 2026Fracture
ADDITIONAL INFORMATION RECEIVED STATING THAT THERE WAS NO PATIENT IMPACT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24598497 ↗MalfunctionMar 13, 2026Fracture
IT WAS REPORTED THAT DURING PROCEDURE THE TOOL BROKE OFF DURING DRILLING. THIS PROCEDURE INVOLVED PROLONGED DRILLING AND CAUSE DELAY OF 4 MINUTES TO TAKE A NEW TOOL AND INSTALL ON THE ATTACHMENT. AT THE TIME OF REPORT PATIENT WAS ALIVE WITH NO INJURY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24594947 ↗MalfunctionDec 30, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING PROCEDURE, SURGICAL CONSUMABLE SUDDENLY BROKE. NO PATIENT IMPACT REPORTED. IT WAS ALSO REPORTED THAT THERE WAS INTERVENTION PERFORMED AND NO DAMAGED PIECE REMAINED IN THE PATIENT'S BODY. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO PATIENT OR STAFF IMPACT AND THERE WAS 10 TO 15 MINS DELAY DURING WHICH THE SURGICAL INSTRUMENTS WERE REPLACED TO CONTINUE THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23920772 ↗
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- MIDAS REX MR8 MR8-AA10Medtronic Powered Surgical Solutions · DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)192 reports
- Midas Rex MR8 MR8-AF02Medtronic Powered Surgical Solutions · DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)189 reports
- NA 5407-FA2-000Stryker Corporation · DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)181 reports
- Indigo™ 1845000Medtronic Xomed, Inc. · DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)165 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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