NA 40-20904SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540604620), received between Feb 19, 2019 and Aug 12, 2020 — classified as 1 injury, 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2020Positioning Failure; Positioning Failure

  AS REPORTED: "CHANGED FROM 4 HOLES PLATE TO 5 HOLES PLATE DUE TO POOR LOCKING OF LOCKING OF THE SCREW. ATTEMPT TO USE THE SAME SCREW, AND 5 HOLES WERE LOCKED."

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10398771 ↗
• InjuryMar 5, 2019Break

  IT WAS REPORTED THAT WHEN THE LOCKING SCREW WAS NOT ABLE TO BE REMOVED AND THE HEAD OF THE SCREW WAS BROKEN. THEREFORE, WHEN THE DOCTOR TRIED TO BE SEPARATED WITH PLATE AND BONE, THE SCREW AND PLATE WERE REMOVED TOGETHER AND A CORTICAL BONE IN FRONT BROKEN A LITTLE. THE PATIENT HAD NO SYMPTOMS AND THE DOCTOR NOT DONE ADDITIONAL TREATMENT. IN ORDER TO BONE FUSION, THE PLATE AND SCREW OF IMPLANTED AT (B)(6) 2018 WAS REMOVED. ADVERSE CONSEQUENCES: A CORTICAL BONE IN FRONT BROKEN A LITTLE.

  Patient problems: Bone Fracture(s)

  MAUDE report 8392759 ↗
• MalfunctionFeb 19, 2019Material Fragmentation

  IT WAS REPORTED THAT THE SCRAPED PIECE WAS CONFIRMED AFTER THE ALL VARIAX FIBULA IMPLANTS WERE REMOVED. THEREFORE, THE PIECE WAS REMOVED AND THE OPERATION WAS FINISHED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8351649 ↗