VariAx 40-20906Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540567451), received between Jul 5, 2022 and Jul 5, 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. How this data works · Data updated Oct 13, 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.

• InjuryJul 5, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT IN (B)(6) 2021, THE PATIENT HAD A DISTAL LATERAL FIBULA PLATE IMPLANTED TO TREAT ANKLE ORIF. 6-7 WEEKS POST OP THE PLATE BROKE WHILST IN SITU, IMPAIRING THE FUNCTION OF THE IMPLANT. ON (B)(6) 2022, THE PATIENT HAD AN ADDITIONAL SURGERY TO REMOVE THE FAILED IMPLANT AND UNDERWENT TIBIOTALARCALCANEAL FUSION. ADDITIONALLY IT WAS REPORTED THAT THE PATIENT HAD FRACTURE NON UNION AND THE PATIENTS FUNCTION WAS IMPAIRED.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Nonunion/Delayed-union Bone Fracture

  MAUDE report 14913519 ↗