MIDAS REX MR8 MR8-7BA15DFRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000501464), received between Jul 4, 2025 and Jul 4, 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.

• MalfunctionJul 4, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE DURING A COCHLEAR IMPLANT PROCEDURE TIP OF THE TOOL BROKE WHILE DRILLING. NO PATIENT IMPACT REPORTED. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. ON FOLLOW-UP IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22402327 ↗