VariAx 40-15041Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613154627882), received between Jun 2, 2023 and Jun 2, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (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.

• MalfunctionJun 2, 2023Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  AS REPORTED: "A STRAIGHT PLATE OF THE VARIAX FOOT SYSTEM WAS REQUIRED FOR A REDUCTION OF THE DISTAL TIBIA AND AT THE TIME OF PLACING THE SCREWS TO FIX IT, THEY WENT THROUGH THE HOLES OF THE PLATE DISPLACING THE PLATE AND IT HAD TO BE REMOVED AND IT WAS NEEDED TO FIND ANOTHER WAY TO MAINTAIN THE REDUCTION INCREASING THE SURGICAL TIME."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17054611 ↗