VARIAX 614620Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613154969784), received between Oct 24, 2017 and Feb 7, 2020 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 7, 2020Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE 2.7 AND 3.5 T10 LOCKING SCREWS DID NOT LOCK INTO THE PLATE IN THE MOST MEDIAL SCREW HOLE AND TWO LATERAL SCREW HOLES IN A SUPERIOR LATERAL PLATE. NEW SCREWS WERE USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9684761 ↗
• MalfunctionFeb 7, 2020Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE 2.7 AND 3.5 T10 LOCKING SCREWS DID NOT LOCK INTO THE PLATE IN THE MOST MEDIAL SCREW HOLE AND TWO LATERAL SCREW HOLES IN A SUPERIOR LATERAL PLATE. NEW SCREWS WERE USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9684760 ↗
• InjuryOct 24, 2017Insufficient Device Problem Information

  DURING EXTRACTION SURGERY, THE SURGEON FOUND THAT THE TISSUE HAS TURNED BLACK.

  Patient problems: Tissue Damage

  MAUDE report 6972970 ↗