VARIAX 614524Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613154969548), received between Dec 5, 2019 and Dec 5, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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.

• MalfunctionDec 5, 2019Fracture; Fracture

  AS REPORTED: "A 2.7 X 24MM LOCKING SCREW (REF: 614524) OF THE ELBOW VARIAX SYSTEM WAS PLACED AND AT THE MOMENT WHEN DR. TIGHTENS IT, THE HEAD IS FRACTURED LEAVING THE REST OF THE SCREW INSIDE THE PATIENT." PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES OR SURGICAL DELAY REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

  MAUDE report 9419492 ↗