Midas Rex MR8 MR8-10MH17Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169989603), received between Dec 31, 2021 and Dec 31, 2021 — 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 18, 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.

• InjuryDec 31, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING CERVICAL FUSION TIP OF THE BLADE BROKE OFF AND THE PIECE REMAINED INSIDE THE PATIENT. ON FOLLOW UP, NO INFORMATION AVAILABLE ON PATIENT CONDITION POST SURGERY AND PROCEDURE DELAY. IT WAS REPORTED THAT THERE IS NO BACK UP DEVICE USED. ADDITIONAL INFORMATION IS STILL ON FOLLOW-UP.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 13125373 ↗