VariAx 54-25677SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540729521), received between Apr 9, 2020 and Sep 20, 2023 — classified as 2 injuries.

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.

• InjurySep 20, 2023Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT A PATIENT REQUIRED REVISION SURGERY DUE TO BREAKAGE OF THE VARIAX PLATE AND INFECTION FROM THE RESULTING OPEN WOUND. BREAKAGE OF THE DEVICE WAS CONFIRMED ON X-RAY FOLLOWING PROGRESSIVE PAIN.

  Patient problems: Failure of Implant; Implant Pain; Wound Infection

  MAUDE report 17780326 ↗
• InjuryApr 9, 2020Material Twisted/Bent; Material Twisted/Bent

  THE SURGEON REPORTED THAT THE PATIENT WAS REVIEWED IN FOLLOW UP CLINIC AND WITHE VARIAX DISTAL RADIUS PLATE HAD BENT. THE PATIENT WILL REQUIRE REVISION, BUT NO DATE HAS BEEN SET YET. ADDITIONALLY REPORTED: MOBILISATION INSTRUCTIONS: 2 WEEKS IN A BACK SLAP CAST, RETURN TO FRACTURE CLINIC AT 2 WEEKS FOR FUTURO SPLIT TO BE REMOVED FOR GENTLE MOBILISATION PATIENT COOPERATION: PATIENT SAYS FOLLOWED PLAN, ONLY USED HAND TO PLAY PLAYSTATION WITH SON.

  Patient problems: Failure of Implant; Injury

  MAUDE report 9946459 ↗