VariAx 54-25385Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613154345519), received between Aug 27, 2019 and Jun 18, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (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.

• InjuryJun 18, 2025Break; Fracture; Break; Fracture

  AS REPORTED: "THE PATIENT WAS HOSPITALIZED DUE TO A DISTAL FRACTURE OF THE RIGHT RADIUS. OPEN REDUCTION AND PLATE SCREW FIXATION WERE PERFORMED 6 DAYS AFTER ADMISSION. A RE-EXAMINATION 8 MONTHS AFTER THE OPERATION REVEALED THAT THE DISTAL FRACTURE OF THE RIGHT RADIUS HAD NOT HEALED AND THE PLATE WAS FRACTURED. PATIENT REQUIRED REVISION SURGERY WAS COMPLETED.".

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 22287652 ↗
• MalfunctionAug 27, 2019Material Puncture/Hole

  AS REPORTED: "DR. WAS DOING AN ORIF DISTAL RADIUS. HE FIRST SELECTED THE PLATE LISTED ABOVE. HE USED THE FIXED ANGLE DRILL GUIDE AND DRILLED IN THE DISTAL HOLES. HE THEN TRIED TO PLACE 2 OF THE 2.4 LOCKING SCREWS LISTED ABOVE. HE USED HAND SCREWDRIVER FOR BOTH (NO POWER AT ALL). WHEN THE SCREWS GOT DOWN TO THE PLATE INTERFACES, THE SCREWS CONTINUED TO SPIN AND WOULD NOT LOCK. HE TRIED BOTH SCREWS IN THE HOLE AS WELL AS TRIED A NEW HOLE WITHOUT ANY CHANGE. HE THEN TOOK THE PLATE OUT AND GRABBED A NEW PLATE. THE SAME TECHNIQUE WAS FOLLOWED AND HE HAD NO ISSUES WITH SCREWS. HE DID STATE, HOWEVER, THAT FOR ONE OF THE DISTAL SCREW HOLES, HE COULD NOT GET THE FIXED ANGLE DRILL GUIDE TO SEAT IN THE HOLE. HE DID NOT HAVE ANY OTHER ISSUES WITH THIS PLATE". REP INDICATED THERE WAS A SURGICAL DELAY IN HAVING TO SWITCH TO ANOTHER PLATE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8938316 ↗