Vantage 351-15-22Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862291417), received between Mar 29, 2022 and Mar 29, 2022 — classified as 1 malfunction.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 29, 2022Break; Break

  AS REPORTED, DURING SURGICAL USE, THE SURGEON USED THE SIZE 2 8MM POLY TO SET ALIGNMENT WITH THE TALUS AND TIBIA TRIALS IN THE 74 YEAR OLD MALE PATIENT. SURGEON PULLED THE POLY OUT WITH A RONJOUR AND THE POLY BROKE. ALL PARTS AND PIECES THAT FALL INTO PATIENT WOUND SITE WERE REMOVED BY THE SURGEON. THE PIECE OF THE POLY WAS REMOVED. THERE WAS NO SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. SALES REP WAS UNABLE TO OBTAIN PHOTOS/X-RAYS. THE DEVICE WILL BE RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13939693 ↗