VariAx 657024Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327069310), received between Sep 25, 2020 and Sep 29, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (2 reports).

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.

• MalfunctionSep 29, 2020Material Fragmentation; Positioning Problem; Material Fragmentation; Positioning Problem

  FOOT INJURY. EXTENDED SURGERY TIME. CHIP FORMATION. SCREW CHANGE 4 X. LENGTH OF SURGICAL DELAY IS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10603214 ↗
• MalfunctionSep 25, 2020Positioning Failure; Material Fragmentation; Positioning Failure; Material Fragmentation

  AS REPORTED: "ANGULAR STABILITY DID NOT WORK. SCREWS HAVE OVERRUN AND CHIPS HAVE COME LOOSE UNDER THE SCREW HEAD (UNFORTUNATELY, CHIPS COULD NOT BE SECURED). REPLACEMENT WAS AVAILABLE. PATIENT INVOLVEMENT WAS REPORTED BUT THE REPORTER IS NOT AWARE OF ANY IMPACT."

  Patient problems: Foreign Body In Patient

  MAUDE report 10586219 ↗