MIDS REX MR8 MR8-10BA20Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000487065), received between Mar 8, 2024 and Mar 8, 2024 — classified as 1 injury.

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.

• InjuryMar 8, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING POSTERIOR CERVICAL FUSION USING NAVIGATION PROCEDURE THE TOOL WAS BROKEN IN HALF AND THE BROKEN PIECES WERE LEFT INSIDE THE PATIENT. HEALTH CARE PROFESSIONAL TRIED TO RETRIEVE THE PRODUCT, BUT WAS UNABLE TO RETRIEVE AND THERE WAS DELAY A IN PROCEDURE FOR 15 MINUTES. IT WAS ALSO REPORTED THAT THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. ADDITIONAL INFORMATION REGARDING THE PATIENT IMPACT WAS BEING FOLLOWED UP.

  Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions; Unintended Radiation Exposure

  MAUDE report 18864009 ↗