MIDAS REX MR8 MR8-SD12MH30Recalls & reported problems
Medtronic Powered Surgical Solutions · TOOL MR8-SD12MH30 MR8 12CM SD MATCH 3MM · Class 2
All models of MIDAS REX MR8 (137)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00763000513849), received between Sep 9, 2026 and Sep 9, 2026 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Fracture” (8 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture8
Patient problems
- Insufficient Information8
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 9, 2026Fracture
It was reported that the tools in the lot were breaking. At the time of the report, patient impact details are unknown.
Patient problems: Insufficient Information
MAUDE report 50688015 ↗MalfunctionSep 9, 2026Fracture
It was reported that the tools in the lot were breaking. At the time of the report, patient impact details are unknown.
Patient problems: Insufficient Information
MAUDE report 50687952 ↗MalfunctionSep 9, 2026Fracture
It was reported that the tools in the lot were breaking. At the time of the report, patient impact details are unknown.
Patient problems: Insufficient Information
MAUDE report 50687950 ↗MalfunctionSep 9, 2026Fracture
It was reported that the tools in the lot were breaking. At the time of the report, patient impact details are unknown.
Patient problems: Insufficient Information
MAUDE report 50687946 ↗MalfunctionSep 9, 2026Fracture
It was reported that the tools in the lot were breaking. At the time of the report, patient impact details are unknown.
Patient problems: Insufficient Information
MAUDE report 50687939 ↗MalfunctionSep 9, 2026Fracture
It was reported that the tools in the lot were breaking. At the time of the report, patient impact details are unknown.
Patient problems: Insufficient Information
MAUDE report 50687880 ↗MalfunctionSep 9, 2026Fracture
It was reported that the tools in the lot were breaking. At the time of the report, patient impact details are unknown.
Patient problems: Insufficient Information
MAUDE report 50687844 ↗MalfunctionSep 9, 2026Fracture
It was reported that the tools in the lot were breaking. At the time of the report, patient impact details are unknown.
Patient problems: Insufficient Information
MAUDE report 50687838 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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