VARIAX 703665Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540652386), received between Mar 25, 2019 and Mar 25, 2019 — classified as 1 malfunction.

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 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.

• MalfunctionMar 25, 2019Break; Fracture; Difficult to Remove; Fracture

  WHEN THE LOCKING SCREW WAS INSERTED AND FINAL TIGHTENED, THE TIP OF THE SCREWDRIVER WAS BROKEN. THE BROKEN TIP OF THE DRIVER REMAINS IN THE SCREW HEAD. ATTEMPTED TO REMOVE IT, BUT COULD NOT EXTRACT IT. SINCE THE BROKEN PART PROTRUDED FROM THE SCREW HEAD, IT WAS MACHINED SO AS TO SHAVE OFF USING AN AIR DRILL, AND IT WAS COMPLETED THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8449768 ↗