MIDAS REX MR8 MR8-SD12MH25DRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000513825), received between Mar 10, 2025 and Mar 10, 2025 — 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 16, 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 10, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE BUR BROKE DURING SINUS SURGERY. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT. IT WAS ALSO REPORTED THAT THERE WAS NO INTERVENTION PERFORMED, NO DAMAGED PIECE REMAINED IN THE PATIENT'S BODY AND THERE WAS NO DELAY IN PROCEDURE. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21560998 ↗