MIDAS REX MR8 MR8-14BA20Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000490225), received between Oct 31, 2022 and Jul 15, 2025 — classified as 2 injuries.

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 16, 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.

• InjuryJul 15, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING THE CERVICAL FUSION (C2-T2) PROCEDURE, THE BALL HEAD OF THE BURR CAME OFF IN THE PATIENT'S SPINE DURING THE DRILLING PROCESS. NO PATIENT IMPACT REPORTED. IT WAS ALSO REPORTED THAT THERE WAS INTERVENTION PERFORMED WHERE THE SURGEON DRILLED OUT SOME BONE AND WAS ABLE TO RETRIEVE THE BURR HEAD. IT WAS ALSO REPORTED THAT PROCEDURE WAS EXTENDED BY 15 MINUTES AND COMPLETED WITH BACK UP PRODUCT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 22512370 ↗
• InjuryOct 31, 2022Fracture; Fracture

  IT WAS REPORTED THAT WHILE PERFORMING A POSTERIOR CERVICAL DECOMPRESSION AND FUSION, THE BALL ON TOOL SNAPPED OFF. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF INJURY. IT WAS ALSO REPORTED THAT ADDITIONAL X-RAYS WERE TAKEN AND C-ARM IS USED TO LOCATE THE HEAD OF TOOL WHICH WAS IN THE PATIENT AND THIS WAS REMOVED BY SURGEON. ADDITIONAL INFORMATION REGARDING THE EVENT IS BEING FOLLOWED-UP.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 15697944 ↗