VARIAX 657430SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327074079), received between Feb 10, 2023 and Mar 30, 2026 — 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 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.

• MalfunctionMar 30, 2026Material Fragmentation

  AS REPORTED: "THE NON-LOCKING SCREW WAS INSERTED INTO THE FRACTURE SITE FOLLOWING DIRECT DRILLING. HOWEVER, UPON TURNING THE DRIVER, A THIN WIRE-LIKE OBJECT EMERGED FROM THE SCREW INSERTION SITE, NECESSITATING ITS REMOVAL. AS FIXATION OF THE FRACTURE BY THE SCREW WAS CONFIRMED, THE SCREW WAS NOT REMOVED AND WAS IMPLANTED IN THE PATIENT'S BODY. SUBSEQUENTLY, PLATE FIXATION WAS PERFORMED USING THE STANDARD TECHNIQUE. THE THIN WIRE-LIKE OBJECT WAS DISCARDED AT THE FACILITY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24734297 ↗
• MalfunctionFeb 10, 2023Material Fragmentation; Material Fragmentation

  AS REPORTED: "EVENT1: METAL FRAGMENTS WERE OBSERVED WHEN A NON-LOCKING SCREW WAS INSERTED IN THE OVAL HOLE AND A LOCKING SCREW IN THE ROUND HOLE, RESPECTIVELY. ONLY THE METAL FRAGMENTS WERE RETRIEVED. EVENT2: THE LOCKING SCREW DID NOT LOCK UPON INSERTION AND WAS SPINNING ALL THE TIME."

  Patient problems: Insufficient Information

  MAUDE report 16353068 ↗