VARIAX 614816Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613154970292), received between Aug 22, 2018 and Aug 22, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Malposition of Device” (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.

• MalfunctionAug 22, 2018Peeled/Delaminated; Malposition of Device

  IT WAS REPORTED THAT THE FOLLOWING ISSUE WITH THE VARIAX 3.5MM CORTICAL SCREW OCCURRED. "THE SCREW WAS INSERTED ROUTINELY INTO A CLAVICLE PLATE. AS IT WAS SCREWED DOWN TO THE PLATE, THE SCREW HEAD DELAMINATED AND THE SCREW WENT RIGHT THROUGH THE PLATE. IT WAS REPORTED THAT ACCORDING TO THE USER, NO EXCESS TORQUE OR ANGLE WAS APPLIED. IT WAS REPORTED THAT THE USER CONFIRMED THE CORRECT 3.7MM DRILL BIT WAS USED DURING THE PROCEDURE.

  Patient problems: No Information

  MAUDE report 7805955 ↗