VARIAX 614518Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613154969517), received between Jan 17, 2019 and Jan 17, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 17, 2019Loose or Intermittent Connection; Positioning Problem

  TWO WEEKS AFTER AN ARTHRODESIS ON THE WRIST, IT WAS FOUND THAT THE USED SCREWS WERE NOT HELD IN THE VARIAX PLATE. THE SURGEON REPORTS THAT HE ALREADY HAD THE FEELING DURING SCREWING THAT THE LOCKING MECHANISM DOES NOT WORK PROPERLY. THE DEVICE WAS REMOVED AND WILL RETURN FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8256793 ↗