Midas Rex MR8 MR8-ASMC09-RRecalls & reported problems
Medtronic Ps Medical, Inc. · ATT MR8-ASMC09-R MR8 9CM MTLCUT 3.2MMRFB · Class 2
All models of Midas Rex MR8 (41)
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 00763000063696), received between May 4, 2026 and Aug 26, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (1 report).
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
- Mechanical Problem1
- Naturally Worn1
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 26, 2026Mechanical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50463913 ↗MalfunctionMay 4, 2026Naturally Worn
IT WAS REPORTED THAT THE ATTACHMENT WAS FOUND WITH BAD BEARINGS. THERE WAS NO PATIENT IMPACT REPORTED. ADDITIONAL INFORMATION RECEIVED ON EVALUATION STATING THE THE INTERNAL TUBE BEARINGS WAS MISALIGNED MADE THIS EVENT REPORTABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25065946 ↗
Other DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) devices
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- 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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