VARIAX 657346SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327087321), received between Jun 10, 2020 and May 17, 2023 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 17, 2023Positioning Failure; Positioning Failure

  AS REPORTED: "S-SCREW DOES NOT LOCK ONTO PLATE.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16950167 ↗
• MalfunctionJun 10, 2020Positioning Failure; Positioning Failure

  IT WAS REPORTED: THE PLATE AND SCREW DID NOT LOCK WELL. I REDID THE DRILL A FEW TIMES, BUT IN THE END IT DIDN'T LOCK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10139615 ↗