Midas Rex MR8 MR8-SP14MH30 (UDI 00763000047153)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000047153), received between May 13, 2022 and May 13, 2022 — 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.

• InjuryMay 13, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE BURR TIP BROKE OFF DURING USE IN SPINAL DECOMPRESSION, ALL FRAGMENTS WERE ACCOUNTED FOR AND INTRAOPERATIVE X-RAY WAS TAKEN. ON FOLLOW UP IT WAS REPORTED THAT THE FRAGMENTS WERE REMOVED FROM THE PATIENT AND DUE TO X-RAY INTERVENTION THE PROCEDURE GOT DELAYED FOR 15 MINUTES. IT WAS ALSO REPORTED THAT THE NAME OF THE PROCEDURE WAS LAMINECTOMY. EVENT NOTIFIED ON: 2022-04-14.

  Patient problems: Device Embedded In Tissue or Plaque; Unintended Radiation Exposure

  MAUDE report 14399493 ↗