VariAx 54-25684Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613252614524), received between Apr 16, 2019 and Aug 13, 2019 — classified as 2 malfunctions.

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

• MalfunctionAug 13, 2019Difficult to Remove

  AS REPORTED: "VARIAX SCREWS LOCKED INTO THE PLATE AND WOULD NOT COME OUT" AND "NEEDED TO COMPLETELY REMOVE OUR PRODUCT AND PUT A DIFFERENT PRODUCT IN." ADDITIONALLY REPORTED: "THESE EACH LOCKED INTO THE PLATE BUT WERE SPINNING AS IF THEY WEREN¿T LOCKED. THE HEADS DID NOT STRIP BUT THE SURGEON WAS UNABLE TO BACK THE SCREW OUT FROM THE PLATE, AND HAD TO RIP THE ENTIRE CONSTRUCT OUT AS ONE. THIS WAS THE FIRST CASE WITH THIS PATIENT AND WAS NOT A REVISION SURGERY."

  Patient problems: Failure of Implant

  MAUDE report 8889986 ↗
• MalfunctionApr 16, 2019Connection Problem

  IT WAS REPORTED THAT, DURING A PRIMARY PROCEDURE ON A RIGHT DISTAL RADIUS, THAT TWO OF THE LOCKING SCREWS (A 16 AND A 20) WOULD NOT LOCK INTO THE VARIAX 2 PLATE. THE SCREWS KEPT SPINNING WHEN FULLY IMPLANTED AND COULD NOT BE BACKED OUT. THE SURGEON DECIDED TO LEAVE THE SCREWS IN AS NON-LOCKING SCREWS. SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 2 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8520384 ↗