VariAx 656412Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327068887), received between Jan 3, 2020 and May 17, 2023 — classified as 1 injury, 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 18, 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.

• MalfunctionMay 17, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "THE EVENT OCCURS IN AN OSTEOSYNTHESIS OF THE LEFT DISTAL RADIUS. AT THE MOMENT WHEN THE SPECIALIST DECIDED TO FIX THE BRANCH OF THE PLATE WITH A 2.7 MM CORTICAL SCREW, THE HEAD OF THE SCREW FRACTURED DESPITE THE FACT THAT ALL THE TECHNIQUE CORRECTLY (2.0 MM DRILL WITH GUIDE, MEASURER AND SCREW WITH T8 SCREWDRIVER) THE SPECIALIST WAS PUTTING THE SCREW AND WHEN GIVING THE LAST TURN WITH THE SCREWDRIVER WITHOUT ANY OVERLOAD OF FORCE THE SCREW FRACTURED LEAVING THE HEAD OF THE SCREW STUCK TO THE BLADE OF THE SCREWDRIVER AND ALL OF ITS STEM INSIDE THE PATIENT, THE SPECIALIST DECIDED TO LEAVE THAT SCREW AND FIX THE PLATE WITH TWO OTHER 2.7 MM SCREWS, ONE LOCKING AND ONE CORTICAL THAT WORK CORRECTLY."

  Patient problems: Foreign Body In Patient

  MAUDE report 16944732 ↗
• InjuryJan 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  VARIAX FOOT PLATE METALOSIS NOTICED UPON REMOVAL ON (B)(6)2019 BY SURGEON. IMPLANTED ON(B)(6)2019 . REMOVAL NOT FOR NON-UNION, JUST REMOVAL OF METALWARE.

  Patient problems: Injury; Reaction

  MAUDE report 9549084 ↗