MIDAS REX MR8 MR8-7TA11Recalls & reported problems
Medtronic Powered Surgical Solutions · TOOL MR8-7TA11 MR8 7CM TAPER 1.1MM · Class 2
All models of MIDAS REX MR8 (137)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000502379), received between Sep 19, 2024 and Aug 8, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (2 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
- Fracture2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 8, 2025Fracture; Fracture
ON FOLLOW UP IT WAS REPORTED THAT THERE WAS 5 MINUTES DELAY UNTIL A NEW BURR COULD BE LOADED AND IT WAS REPORTED THAT THERE WAS NO ADVERSE REACTION FROM PATIENT DUE TO WAIT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22752207 ↗MalfunctionSep 19, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING A PROCEDURE, WHEN A PILOT HOLE WAS BEING DRILLED THE TOP OF THE DRILL BIT BROKE OFF. 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 5 MINS DELAY IN PROCEDURE. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT(S).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20254749 ↗
Other DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) devices
- NA EMAX2PLUSSynthes GmbH · DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)2,623 reports
- MIDAS REX MR8 MR8-AF02Medtronic Powered Surgical Solutions · DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)952 reports
- Indigo™ 1845000Medtronic Xomed, Inc. · DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)416 reports
- MIDAS REX MR8 MR8-AS07Medtronic Powered Surgical Solutions · DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)232 reports
- 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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