VariAx 54-25391Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613154379491), received between Jul 12, 2018 and Aug 9, 2022 — 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 18, 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.

• InjuryAug 9, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT A VARIAX 2 DISTAL RADIUS XXL PLATE WAS FOUND TO BE BENT A COUPLE OF WEEKS AFTER SURGERY DURING A CLINIC FOLLOW-UP. POTENTIAL CAUSE FOR THE BENDING OF THE PLATE IDENTIFIED AS A VOID IN THE BONE. THE SURGEON SPOKE ABOUT IT WITH THE PATIENT DURING FOLLOW UP AND NO REVISION IS PLANNED AS OF NOW. PATIENT WAS IN CAST AND LIFTING HEAVY OBJECTS FEW WEEKS POST-OPERATIVE. PATIENT RETURNED WITH SOME PAIN AND X-RAYS CONFIRMED BENT PLATE.

  Patient problems: Implant Pain

  MAUDE report 15191757 ↗
• InjuryJul 12, 2018Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT ORIF DISTAL RADIUS ON (B)(6)2018 WITH VARIAX DISTAL RADIUS SYSTEM. CAST WAS REMOVED IN (B)(6) 2018. IT WAS REPORTED THAT THE PATIENT ALLEGEDLY HEARD A "POP" A FEW WEEKS LATER. PATIENT WAS BOOKED FOR REMOVAL OF BROKEN HARDWARE AND REVISION ORIF DISTAL RADIUS WITH SYNTHES PLATING SYSTEM ON (B)(6) 2018.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7682476 ↗