VARIAX 628026Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613252441922), received between Sep 19, 2018 and Sep 19, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Mechanical Problem” (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.

• MalfunctionSep 19, 2018Mechanical Problem

  PRIMARY PROCEDURE, RIGHT CLAVICLE. IT WAS REPORTED THAT IN IMPLANTING THE VARIAX2 CORE 3.5 LOCKING SCREWS INTO THE CLAVICULAR PLATE, THE SCREWS WOULD NOT LOCK - THEY KEPT SPINNING WHEN THEY SHOULD HAVE LOCKED. REP OBTAINED LOCKING SCREWS FROM A VARIAX 1 ANKLE SOLUTION SET, WHICH LOCKED AS EXPECTED. THE PLATE IS IMPLANTED AND THE REPORTED SCREWS ARE AVAILABLE FOR RETURN. REP REPORTED THAT SURGEON WAS FOLLOWING THE SURGICAL TECHNIQUE THROUGHOUT THE PROCEDURE. THERE WAS A SURGICAL DELAY OF 5 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7891404 ↗