MIDAS REX MR8 MR8-T12MH25MRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000514136), received between Mar 12, 2026 and Mar 12, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 12, 2026Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, AFTER TESTING AND CORRECT ASSEMBLY OF THE HANDPIECE, THE TELESCOPIC TOOL WAS HANDED TO THE SURGEON. UPON ACTIVATING THE FOOT PEDAL OUTSIDE THE PATIENT, THE BURR HEAD DETACHED AND WAS EXPELLED FROM THE DEVICE AT THE START OF THE PROCEDURE. THE PRODUCT DID NOT CONTACT THE PATIENT, AND NO FRAGMENTS REMAINED INSIDE THE PATIENT'S BODY. THE DEVICE WAS DAMAGED, AND THE PROCEDURE EXPERIENCED AN APPROXIMATE 2-MINUTE DELAY WHILE A BACKUP PRODUCT WAS USED TO CONTINUE AND COMPLETE THE SURGERY. THE PATIENT OUTCOME WAS REPORTED AS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24577800 ↗