MIDAS REX MR8 MR8-SP12MH30TRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000513948), received between Nov 6, 2025 and Sep 9, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2026Loss of Power

  It was reported that during surgery, the burr was not working and no irrigation was used. The procedure was completed with backup product. There was no known patient impact with this event.

  Patient problems: Insufficient Information

  MAUDE report 50684694 ↗
• MalfunctionNov 6, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DRILL BIT IS COMING OUT OF THE SHEATH. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23487251 ↗
• MalfunctionNov 6, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DRILL BIT IS COMING OUT OF THE SHEATH . NO PATIENT IMPACT WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23487205 ↗