VariAx 657114SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327071535), received between Mar 17, 2020 and Mar 17, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Insert” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2020Difficult to Insert; Difficult to Insert

  AS REPORTED: "WHEN THE VARIAX SCREW (657114S) WAS INSERTED INTO THE PLATE, IT DID NOT BITE THE BONE AND THE SCREW SLIPPED. THIS WAS A CORTICAL SCREW, WHICH HAD FIRMLY ENGAGED THE OPPOSITE CORTICAL BONE ON THE IMAGE. I MANAGED TO FIX IT WITH AN ALTERNATIVE SCREW (657414S). THE PROCEDURE WAS TERMINATED WITH UNKNOWN CAUSE. THERE WAS NO PROBLEM WITH THE SCREW LENGTH."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9845751 ↗