MIDAS REX MR8 MR8-9BA75Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000506544), received between Jan 9, 2025 and Jun 9, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 2025Overheating of Device; Loss of Power; Smoking; Overheating of Device; Loss of Power; Smoking

  IT WAS REPORTED THAT DURING CRANIECTOMY, MIDAS REX MR8 BURR (FROM MEDTRONIC) WAS USED TO MAKE THE HOLE AND THE BURR DID NOT FULFILL ITS FUNCTION OF PERFORATING THE BONE, PRODUCED TOO MUCH SMOKE, AND SMELLED BURNT. SIGNIFICANT FORCE HAD TO BE EXERTED TO ACHIEVE PERFORATION. NO PATIENT IMPACT REPORTED. IT WAS REPORTED THAT THERE WAS NO INTERVENTION PERFORMED AND PROCEDURE WAS COMPLETED WITH BACKUP PRODUCTS. ON FOLLOW UP, IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22164999 ↗
• MalfunctionJan 9, 2025Overheating of Device; Smoking; Dull, Blunt; Overheating of Device; Smoking; Dull, Blunt

  IT WAS REPORTED THAT DURING A CRANIAL BIOPSY PROCEDURE THE DRILL BIT AS SOON AS IT TOUCHED THE BONE IMMEDIATELY STARTED GETTING EXTREMELY HOT, PRODUCING SMOKE AND WASN'T CUTTING. THERE WAS NO IMPACT ON THE PATIENT OUTCOME. IT WAS ALSO REPORTED THAT THE SURGEON SWITCHED TO A DIFFERENT BIT AND PROCEEDED WITH THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21110838 ↗