VariAx 40-20907Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540567468), received between Sep 14, 2022 and Sep 14, 2022 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 14, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE DOCTOR WAS REVISING AN ANKLE ORIF. THE VARIAX DISTAL FIBULA PLATE WAS NOT ORIGINALLY COMING OUT BUT THE DOCTOR NOTICED THAT THE PLATE WAS BROKEN. HE FELT LIKE THE PLATE BROKE IN AN USUAL PLACE. HE TOOK THE PLATE AND SCREWS OUT AND ADDED A LONGER VARIAX DISTAL FIBULA PLATE.

  Patient problems: Implant Pain; Swelling/ Edema

  MAUDE report 15422123 ↗