MIDS REX MR8 MR8-10MH22Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000487522), received between May 11, 2023 and May 11, 2023 — 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.

• InjuryMay 11, 2023Fracture; Overheating of Device; Fracture; Overheating of Device

  IT WAS REPORTED DURING AN ANTERIOR CERVICAL FUSION, WHEN THE HEALTH CARE PROFESSIONAL WAS USING THE DRILL, THE TIP OF THE TOOL BECAME TOO HOT AND IT BROKE OFF INSIDE THE PATIENT'S CERVICAL SPINE. THE HEALTH CARE PROFESSIONAL PROCEEDED TO REMOVE THE BROKEN TIP AND VERIFIED WITH X-RAY THAT NO REMAINING FRAGMENTS WERE LEFT INSIDE THE PATIENT. ON FOLLOW UP, IT WAS REPORTED THAT THERE WAS A PROCEDURE DELAY OF 5 MINUTES WHICH INVOLVED FINDING THE ITEM, PERFORMING THE X-RAY AND GETTING ANOTHER TOOL OPENED. IT WAS ALSO REPORTED THAT PATIENT IS DOING AS EXPECTED AFTER PROCEDURE.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 16911859 ↗