NA 40-20905SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540604637), received between Feb 7, 2017 and Nov 15, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionNov 15, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THERE WAS METAL DEBRIS AFTER REMOVING THE PLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15796085 ↗
• MalfunctionFeb 7, 2017Difficult to Insert

  DURING VARIAX FIBULA SURGERY, A LOCKING SCREW DID NOT LOCK TO A DISTAL HOLE OF A VARIAX FIBULA PLATE. THE SURGEON EXCHANGED IT TO A NEW SCREW BUT THE SITUATION DID NOT CHANGE. THERE WAS APPROX. 3 MIN DELAY IN THE SURGERY. THE SURGEON DID NOT INSERT ANY SCREW TO THE SCREW HOLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6308750 ↗