VARIAX 629303SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327082920), received between Sep 20, 2019 and Sep 20, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Damaged by Another Device” (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 18, 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.

• MalfunctionSep 20, 2019Positioning Failure; Device Damaged by Another Device; Positioning Problem; Positioning Failure; Device Damaged by Another Device

  AS REPORTED: "DURING SURGERY, THE LOCKING SCREW DID NOT LOCK TO THE PLATE. THE SCREW WAS EXCHANGED TO A NEW ONE, BUT THE SITUATION WAS NOT CHANGED. BECAUSE THE HOLE OF THE PLATE WAS LOOKED CLEARLY BIGGER THAN THE OTHER HOLES AND A DEBRIS WAS FOUND, THE PLATE WAS ALSO EXCHANGED TO A NEW ONE. THE PROCEDURE WAS FINISHED WITHOUT OTHER PROBLEM." NO SURGICAL DELAY OR ADVERSE CONSEQUENCES WERE REPORTED.

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

  MAUDE report 9099649 ↗