VARIAX 657414SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327073799), received between Oct 1, 2019 and Dec 22, 2023 — classified as 2 malfunctions.

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

• MalfunctionDec 22, 2023Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT 1 SCREWS HEAD SNAPPED OFF DURING INSERTION. THE SCREW SHAFT IS STILL IN THE PATIENT. THE SCREW HEAD HAS BEEN SAVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18387215 ↗
• MalfunctionOct 1, 2019Device Damaged Prior to Use; Contamination /Decontamination Problem; Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE SURGEON FOUND THE FOREIGN MATERIAL ON THIS SCREW AT OPENING OF PACKAGING. INSTEAD OF THIS, OTHER ONE WAS USED FOR A PROCEDURE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY OR ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9143470 ↗