VariAx 54-25674Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613252614463), received between Sep 19, 2018 and Sep 30, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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.

• InjurySep 30, 2025Material Twisted/Bent; Material Twisted/Bent

  AS REPORTED: "A DORSAL WEDGE OSTEOTOMY WAS PERFORMED TO ACHIEVE INCREASED RADIAL HEIGHT AND CORRECT THE DISTAL DORSAL DEFORMITY OF THE RADIUS. THE PLATE WAS FIXED DISTALLY USING LOCKING SCREWS, AND WITH THE USE OF A LAMINA SPREADER, GREATER RADIAL HEIGHT WAS OBTAINED, WHICH WAS CONFIRMED VIA X-RAY. THE PLATE WAS THEN FIXED PROXIMALLY USING A CORTICAL SCREW; HOWEVER, PLATE FAILURE WAS OBSERVED DUE TO BENDING. AS A RESULT, THE SURGEON PROCEEDED TO REMOVE THE PLATE AND REPLACE IT WITH A NEW ONE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23186701 ↗
• MalfunctionSep 19, 2018Loose or Intermittent Connection; Improper or Incorrect Procedure or Method

  PRIMARY PROCEDURE, RIGHT DISTAL RADIUS. AS REPORTED: "DR. (B)(6) WAS USING A 2.4X20 VARIAX2 LOCKING SCREW AND WHEN DOING HIS FINAL TIGHTENING THE SCREW WOULD NOT LOCK. HE WAS ABLE TO KEEP THE SCREW IN PLACE BUT THE LOCKING MECHANISM WAS NOT FULLY UTILIZED. NEITHER THE PATIENT NOR THE OUTCOME OF THE SURGERY WAS AFFECTED. REP REPORTED THAT X-RAYS, MEDICAL RECORDS, AND FURTHER INFORMATION ARE NOT AVAILABLE DUE TO HOSPITAL POLICY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7891486 ↗