Midas Rex™ CB11BA40DRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169766228), received between Mar 28, 2025 and Mar 28, 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 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.

• MalfunctionMar 28, 2025Fracture; Fracture

  IT WAS REPORTED THAT BOTH BURS BROKE AFTER A FEW SECONDS DURING THE SET UP. THERE WERE NO FRAGMENTS LEFT INSIDE THE PATIENT AND THERE WAS NO DELAY IN PROCEDURE AS A RESULT OF THE EVENT. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT. THE PROCEDURE WAS COMPLETED WITH THE BACKUP PRODUCT. UPON FOLLOW UP IT WAS CONFIRMED THAT THERE WAS NO ADDITIONAL INTERVENTION WAS PERFORMED AND THE PROCEDURE WAS SPINE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21718034 ↗