VariAx 54-25683Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613252614500), received between Aug 25, 2021 and Aug 25, 2021 — classified as 1 malfunction.

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

• MalfunctionAug 25, 2021Positioning Failure; Positioning Failure

  AS REPORTED: "THE SURGEONS WERE PERFORMING AN OPEN REDUCTION PROCEDURE OF THE RIGHT DISTAL RADIO WHICH THE DORSAL PART WAS SOMETHING COMMINUTE, A RIGHT EXTRACTOR PLATE IS PLACED. DISTAL RADIO 49MM REFERENCE 5425683 LOT 1000428950 THE OVAL HOLE OF THE BRANCH IS FIXED TO THE DISTAL PART OF THE PLATE WITH A CORTICAL SCREW OF 2.7X 16MM VERIFYING WITH X-RAYS AND THEN FIXING THE DISTAL PART USING THE 2.0MM LOCKING GUIDE HOLES WHICH DO NOT BLOCK, SEVERAL DRILLINGS ARE MADE IN DIFFERENT HOLES BUT THE SAME HAPPENED WITHOUT BLOCKING THE SCREWS, WHICH HAD BEEN USED 2.4MM X 18MM, 20MM, 22MM BLOCK T. AND THEN THE LAST BRANCH OF THE DISTAL HOLE IS FIXED PROXIMAL PART OF THE PLATE WITH A 2.7X14MM CORTICAL SCREWS, IT IS DECIDED TO REMOVE THE PLATE TO VERIFY THE DIRECTION OF THE HOLES AND THEIR LOCKING FUNCTION, SMART LOOK SYSTEM, BUT THEY DO NOT BLOCK THE ORIFICES AND THEY ARE MADE WITH A NEW SCREWS. THE SURGEON WAS ANGRY BY SUCH EVENT WHICH DECIDES NOT TO USE THE DISTAL RADIO SYSTEM WITH THE USED PLATE ANY MORE AND TO FIX THE H, DISTAL RADIO OF L APTE WITH KIRSCHNER NAILS 1.25 AND 1.1MM."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12365698 ↗