MIDAS REX MR8 MR8-SP12MH30 (UDI 00763000513924)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000513924), received between Oct 9, 2024 and Jan 17, 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.

• MalfunctionJan 17, 2025Fracture; Fracture

  ON FOLLOW-UP IT WAS CONFIRMED THAT THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21178929 ↗
• MalfunctionOct 9, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE BUR WAS FOUND TO BE DISLODGED FROM THE TOOL AFTER THE PROCEDURE. IT WAS ALSO REPORTED THAT THERE WAS NO INTERVENTION PERFORMED, NO PROCEDURE DELAY AND THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. ON FURTHER FOLLOW-UP IT WAS REPORTED THAT BURR TIP IS BROKEN/COMPLETELY DISLODGED FROM THE CLEARVIEW TOOL, AND THE ENTIRE PIECE DROPPED OUT. NO FRAGMENTS DROPPED INTO THE SURGICAL FIELD OR PATIENT¿S BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20407325 ↗