NA 40-20907SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04546540604651), received between May 29, 2019 and Dec 14, 2021 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Positioning” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "THE WOUND FROM THE SURGERY USING THE VARIAX FIBULA PLATE IS PAINFUL."

  Patient problems: Pain

  MAUDE report 13002889 ↗
• MalfunctionApr 21, 2020Positioning Failure; Positioning Failure

  AS REPORTED: "IN THE VARIAX FIBRA OPERATION THE PROXIMAL SCREW DID NOT LOCK TO THE PLATE. THE SCREW WAS IDLING. THE ANGLE TO THE PLATE WAS NOT STEEP AND THE SCREW OF 12MM WAS INSERTED FOR THE 14MM MEASUREMENT, AND THUS DRILL WAS ENOUGH. THE WOUND WAS CLOSED WITHOUT INSERTING ANOTHER SCREW."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9984124 ↗
• MalfunctionNov 20, 2019Difficult or Delayed Positioning; Difficult or Delayed Positioning

  DURING VARIAX FIBULA SURGERY, A LOCKING SCREW DID NOT LOCK TO THE MOST DISTAL HOLE OF THE PLATE. THE SURGEON INSERTED THE SCREW AS IT IS AND FINISHED THE SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9349741 ↗
• MalfunctionMay 29, 2019Manufacturing, Packaging or Shipping Problem

  THE HOSPITAL REPORTED THE FOLLOWING EVENT: "THE SURGEON REQUESTED A 7-HOLE FIBULA PLATE BOX CALLED 7T GIVEN. AT THE OPENING THE PLATE IS A 9 HOLES".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8651567 ↗