VariAx 54-25374Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613154345465), received between Aug 21, 2023 and Sep 25, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (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 16, 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 25, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  AS REPORTED: "IT WAS REPORTED THAT THE LOCKING SCREW WOULD NOT LOCK FIRMLY INTO THE LOCKING HOLE, AND THE SCREW WOULD JUST SPIN BOTH CLOCKWISE AND COUNTERCLOCKWISE. THE SURGEON COULDN'T REMOVE THE SCREW AND WITH ONLY ONE OTHER GOOD SCREW IN THE PROXIMAL SHAFT OF THE PLATE ABOVE HIS OSTEOTOMY, THE SURGEON HAD TO REDO THE CONSTRUCT WITH A LONGER PLATE. UPON PUTTING ON THE NEW PLATE (SAME VERSION OF PLATE BUT LONGER), THE SURGEON HAD THE SAME SCENARIO. UPON PUTTING ON THE PLATE USING THE IDENTICAL DRILL HOLES IN THE DISTAL END OF PLATE HAD HIS 3RD SCREW IN THE RADIAL STYLOID HOLE SPIN IN BOTH DIRECTIONS. THE LOCKING SCREW SPUN AGAIN AND COULDN'T BE REVERSED OUT OF THE PLATE. AT THIS POINT, THE SURGEON WAS REPORTEDLY FRUSTRATED AND HAD TO REMOVE THE PLATE AND SCREWS AND DECIDED TO CHANGE CONSTRUCTS USING ANOTHER VENDOR'S PLATE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A DIFFERENT DEVICE.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23144774 ↗
• InjuryAug 21, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: "PROCEDURE COMPLETED SUCCESSFULLY IN 2017. IN 2021, THE PLATE WAS EXTRACTED. THIS PI IS RELATED TO A COURT CASE PENDING BETWEEN THE PATIENT AND THE HOSPITAL."

  Patient problems: Insufficient Information

  MAUDE report 17586028 ↗