MIDAS REX MR8 MR8-SP14MH30 (UDI 00763000514006)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000514006), received between Mar 25, 2025 and Sep 24, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DEVICE WITH THE REPORT OF DETACHMENT OF COMPONENT. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23133241 ↗
• MalfunctionMar 25, 2025Fracture; Fracture

  IT WAS REPORTED THAT IN THE PROCEDURE OF POSTERIOR SPINAL FUSION DEVICE SHAFT BROKE UPON STARTUP. NO PATIENT IMPACT REPORTED. THE PROCEDURE WAS COMPLETED WITH THE BACKUP PRODUCT. NO ADDITIONAL INTERVENTION WAS PERFORMED OR PLANNED AS A RESULT OF THIS EVENT. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. UPON FOLLOW UP IT WAS CONFIRMED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21685289 ↗