MIDAS REX MR8 MR8-T12MH25DRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000514112), received between Nov 6, 2024 and Apr 2, 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.

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.

• MalfunctionApr 2, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE TOOL WAS BROKEN IN HALF, WHEN SURGEON WAS DRILLING. NO PATIENT IMPACT REPORTED. THE PROCEDURE WAS COMPLETED WITH BACKUP DEVICE AND THERE WAS NO INTERVENTION PERFORMED AND NO FRAGMENTS LEFT INSIDE THE BODY. ON FOLLOW UP, IT WAS CONFIRMED WITH THE HEALTH CARE PROFESSIONAL THAT THERE WAS NO PATIENT OR STAFF IMPACT AND L4/L5 ENDOSCOPIC DECOMPRESSION (RIGHT SIDE) PROCEDURE WAS PERFORMED. ON FOLLOW UP, IT WAS REPORTED THAT THERE IS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21749813 ↗
• MalfunctionNov 6, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE DRILL WAS FOUND TO NOT BE WORKING MID WAY, AND DISCOVERED THAT THE DRILL BIT HAD BROKEN INTO 2 PIECES. NO PATIENT IMPACT REPORTED. IT WAS ALSO REPORTED THAT THERE WAS NO INTERVENTION PERFORMED AS A RESULT OF THE EVENT AND NO BROKEN PIECES OF THE REPORTED PRODUCT REMAIN INSIDE THE PATIENT'S BODY. THERE WAS NO PROCEDURE DELAY DUE TO THE EVENT AND THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. ON FURTHER FOLLOW-UP IT WAS REPORTED THAT THE PROCEDURE WAS ENDOSCOPY DECOMPRESSION, THERE IS NO RECORDED STAFF IMPACT AND THE PATIENT IS DOING GOOD, ALIVE WITHOUT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20618666 ↗