MIDAS REX MR8 MR8-14MH30 (UDI 00763000490140)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000490140), received between Apr 11, 2024 and Aug 5, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Dull, Blunt” (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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 5, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE DEVICE WITH THE REPORT OF DISSECTING TOOL BREAKAGE. THE TIP OF THE MATCHSTICK BUR WAS BROKE OFF IN THE BONE DURING USE. IT WAS ALSO REPORTED THAT IT IS TOO RISKY TO REMOVE AND LEFT IT IN. NO PATIENT IMPACT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22711306 ↗
• MalfunctionJan 14, 2025Overheating of Device; Smoking; Dull, Blunt; Overheating of Device; Smoking; Dull, Blunt

  IT WAS REPORTED THAT THE BURR WAS SMOKING AND BURNING THE BONE. IT WAS REPORTED THAT THERE WAS NO INTERVENTION PERFORMED AND NO DELAY IN THE PROCEDURE. IT WAS ALSO REPORTED THAT THE PROCEDURE WAS COMPLETED WITH THE REPORTED PRODUCT. ADDITIONAL INFORMATION REGARDING THE PATIENT IMPACT WAS BEING FOLLOWED UP FROM THE FACILITY.

  Patient problems: Burn(s); No Clinical Signs, Symptoms or Conditions

  MAUDE report 21146939 ↗
• MalfunctionApr 11, 2024Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE MATCH HEAD BIT IS CHARRING UP QUICKLY, ESPECIALLY DURING THE DECOMPRESSION PHASE OF THE PROCEDURE. THE BLADE IS QUICKLY BECOMING DULL AND WEARING DOWN. THERE WERE NO FRAGMENTS LEFT INSIDE THE PATIENT, AND THERE WAS NO DELAY IN THE PROCEDURE AS A RESULT OF THE EVENT. NO PATIENT IMPACT WAS REPORTED. AN INTERVENTION IS PERFORMED. THE PROCEDURE WAS COMPLETED WITH THE BACKUP PRODUCT. ON FOLLOW-UP, IT WAS REPORTED THAT THE PROCEDURE WAS LUMBAR FUSION, THERE WAS A DELAY OF 5¿10 MINUTES DUE TO THE DISPOSABLE DRILL BIT BECOMING DULL, THERE WERE NO FRAGMENTS LEFT INSIDE THE PATIENT AND IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT. ADDITIONAL NON-ROUTE ACTIONS WERE TAKEN TO PREVENT IMPACT, LOWERING THE RPM ON THE POWER CONSOLE AS PER RECOMMENDATION, AND THE ISSUE STILL PERSISTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19086125 ↗