VARIAX 657450Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327074260), received between Nov 19, 2018 and Sep 10, 2021 — classified as 2 malfunctions.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A 15MM 3.5 NON-LOCKING SCREW WAS USED IN A SURGERY AND THE THREADS BEGAN SEPARATING FROM THE SCREW. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12453817 ↗
• MalfunctionNov 19, 2018Break

  IT WAS REPORTED THAT AS THE SCREW WAS BEING REMOVED TO BE CHANGED FOR SHORTER ONE, THE THREADS SHEARED OFF COMPLETELY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8084408 ↗