VARIAX 657328SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327087055), received between Feb 10, 2020 and Apr 21, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (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 16, 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.

• MalfunctionApr 21, 2021Positioning Failure; Positioning Failure

  IT WAS REPORTED: "THE LOCKING SCREW DID NOT LOCK AND WAS SPINNING (IDLING) ALL THE TIME. THE SURGEON STATED THAT THERE COULD BE PROBLEM WITH THE SCREW OR THE LOCKING HOLE BECAUSE A SHORTER SCREW WAS CHOOSE AND THE ANGLE OF SCREW WAS NOT EXCESSIVE. WHEN THE SURGEON PUT A NEW SCREW OF THE SAME SIZE WITH THE SAME HOLE, IT WAS LOCKED WITHOUT PROBLEM. THE SAME THING HAPPENED AGAIN, AND WHEN THE SURGEON REINSERTED THE SCREW OF THE SAME SIZE, IT WAS LOCKED NORMALLY".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11704222 ↗
• MalfunctionApr 21, 2021Positioning Failure; Positioning Failure

  IT WAS REPORTED: "THE LOCKING SCREW DID NOT LOCK AND WAS SPINNING (IDLING) ALL THE TIME. THE SURGEON STATED THAT THERE COULD BE PROBLEM WITH THE SCREW OR THE LOCKING HOLE BECAUSE A SHORTER SCREW WAS CHOOSE AND THE ANGLE OF SCREW WAS NOT EXCESSIVE. WHEN THE SURGEON PUT A NEW SCREW OF THE SAME SIZE WITH THE SAME HOLE, IT WAS LOCKED WITHOUT PROBLEM. THE SAME THING HAPPENED AGAIN, AND WHEN THE SURGEON REINSERTED THE SCREW OF THE SAME SIZE, IT WAS LOCKED NORMALLY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11704194 ↗
• MalfunctionFeb 10, 2020Migration; Migration

  AS REPORTED: "IN 2006 MAYO PLATE WAS USED FOR NONUNION FRACTURE OF THE DISTAL HUMERUS. ON (B)(6) 2019, MAYO PLATE WAS REMOVED, AND MEDIAL AND LATERAL VARIAX ELBOW PLATE WAS IMPLANTED. TWO WEEKS AFTER REVISION SURGERY, BACK-OUT HAPPENED. (1 PROXIMAL LOCKING SCREW, 2 PROXIMAL CORTICAL SCREW, MOST DISTAL LOCKING SCREW OF LATERAL PLATE)". NO ADDITIONAL SURGERY IS PLANNED.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 9690152 ↗