MIDAS REX MR8 MR8-ND13BA40DCRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000513757), received between Apr 17, 2025 and Apr 8, 2026 — 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.

• MalfunctionApr 8, 2026Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING REMOVAL OF SKULL BASE BONE, THE DISTAL TIP OF THE DEVICE FRACTURED. IT WAS REPORTED THAT THE SURGERY WAS DELAYED BY ABOUT 20 MINUTES AND HAD TO BE COMPLETED USING BACKUP PRODUCTS. THERE WERE NO BROKEN PIECES OF THE DEVICE LEFT IN THE PATIENT'S BODY. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24814833 ↗
• MalfunctionApr 17, 2025Fracture; Fracture

  IT WAS REPORTED THAT UPON OPENING OF ITEM IN HOSPITAL, CLEARVIEW IS WITHOUT DRILLING TIP. THERE WAS NO PATIENT INVOLVED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21857394 ↗