VARIAX 657334Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327087192), received between Jul 18, 2019 and Jul 18, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (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.

• MalfunctionJul 18, 2019Material Erosion; Material Deformation; Material Disintegration; Material Erosion; Material Deformation

  IT WAS REPORTED THAT, DURING A PRIMARY PROCEDURE ON A LEFT FOOT, WHEN DRIVING THE SCREW THROUGH THE HOLE IN THE PLATE FOLLOWING THE SURGICAL TECHNIQUE, METAL SHAVINGS WERE COMING OFF THE THREADS OF THE SCREW. THE SCREW AND SHAVINGS WERE REMOVED. ANOTHER SCREW WAS INSERTED IN THE SAME HOLE OF THE PLATE AND WAS ABLE TO BE INSERTED WITH NO METAL SHAVINGS CAUSED. SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 45 SECONDS. NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8805228 ↗