eZ-Fix 800-200Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00841132142837), received between Oct 15, 2024 and Oct 15, 2024 — classified as 1 malfunction.

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 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.

• MalfunctionOct 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  DATE OF INITIAL SURGERY: (B)(6) 2024. DETAILS: RIGHT ULNA ACUTE CORRECTION, EXCISION OF OSTEOCHONDROMA, AND APPLICATION OF RAIL FIXATOR. SURGEON: (B)(6). COMPLICATION: LOOSENING OF PROXIMAL CLAMP OF RAIL CAUSING LOSS OF CORRECTION 6 WEEKS INTO LENGTHENING PROCESS. THIS WAS PICKED UP ON X-RAY ONE WEEK PRIOR TO THE REVISION SURGERY AND THE PATIENT HAD NOTICED THE CLAMP HAD SHIFTED AND WAS NO LONGER PERPENDICULAR TO THE HALF PINS. WHEN WE REVISED THE RAIL FIXATOR INTRA-OP WE NOTED THAT ALL OF THE LOCKING MECHANISMS ON THE PROXIMAL CLAMP WERE LOOSE SO SUSPECT FAILURE OF THIS CLAMP ALTOGETHER.

  Patient problems: Failure of Implant

  MAUDE report 20458153 ↗