Midas Rex MR8 MR8-SP12MH30 (UDI 00763000047078)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000047078), received between Apr 2, 2025 and Apr 2, 2025 — classified as 1 malfunction.

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.

• MalfunctionApr 2, 2025Fracture; Fracture

  IT WAS REPORTED THAT TIP OF THE TIP OF CLEAR VIEW BURR BROKE OFF WHILE SURGEON WAS USING THE BURR TO DRILL INTO BONE. THE BROKEN TIP WAS LOCATED REMOVED FROM THE PATIENT AND THE BROKEN TIP PLUS BURR WERE ISOLATED FROM THE PATIENT AND PROCEDURE. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE EVENTS OR OUTCOMES FOR THE PATIENT, NO DELAY IN SURGERY AND PROCEDURE WAS COMPLETED WITH A BACKUP PRODUCT. ON FOLLOW-UP THE PROCEDURE WAS REPORTED AS L2/3 ROBOTICALLY ASSISTED POSTERIOR LUMBAR INTERBODY FUSION AND THERE WERE NO FRAGMENTS LEFT INSIDE THE PATIENT, IT WAS CONFIRMED WITH THE HEALTH CARE PROFESSIONAL THAT THERE WAS NO PATIENT OR STAFF IMPACT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21749643 ↗