Vantage 351-90-04Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885862301505), received between Jun 4, 2021 and Jul 5, 2023 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 5, 2023Break; Break

  IT WAS REPORTED THAT DURING SURGICAL USE THE EXPERIENCED SURGICAL TEAM FACED A BREAKAGE OF THE SCREW. NO SCLEROTIC BONE WAS DETECTED. NO PARTS REMAINED IN SITU. THE BROKEN PART OF THE SCREW REMAINED IN THE TALUS. THERE WAS A 5 MINUTE DELAY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION PROVIDED. PRODUCT NOT RETURNING - BROKEN PART WAS DISPOSED AFTER SURGERY.

  Patient problems: Failure of Implant

  MAUDE report 17255576 ↗
• InjuryMay 8, 2023Break; Fracture; Break; Fracture

  AS REPORTED, DURING SURGICAL USE, THE SURGEON FACED A FLATTENED AND HARD BONE. WHILE PLACING THE TALAR TRIAL IT WAS NOTICED THAT THE TALAR TRIAL SHOWED NON-OPTIMAL POSITIONING. AFTER REPOSITIONING THE TALAR TRIAL, THE SURGEON HAD TO USE MORE FORCE TO SCREW IT IN. WHILE SCREWING IT IN, THE SCREW BROKE. THE SURGEON DECIDED NOT TO REMOVE THE SCREW TO PREVENT THE BONE FROM FURTHER DAMAGE AFTER TWO ATTEMPTS OF SETTING THE SCREW. THERE WAS NO REPORTED SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Failure of Implant; Foreign Body In Patient

  MAUDE report 16885688 ↗
• InjuryMay 1, 2023Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE, WHEN THE TALAR TRIAL SCREW WAS DRILLED INTO THE BONE, IT BROKE WITHOUT ANY PREVIOUS SIGN OF DAMAGE. THE BONE WASN´T SCLEROTIC BUT HARD. THE SECOND SCREW FIXED THE TALAR TRIAL WITHOUT ANY FURTHER COMPLICATIONS. THE SURGEON DECIDED NOT TO REMOVE THE BROKEN SCREW, AS IT MIGHT HAVE CAUSED SEVERE DAMAGE IN THE TALUS. THERE WERE NO SURGICAL DELAYS. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE IS AVAILABLE FOR RETURN. X-RAYS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16846849 ↗
• MalfunctionJun 4, 2021Break; Break

  AS REPORTED, DURING AN ANKLE PROCEDURE ON A (B)(6) Y/O FEMALE PATIENT, A SCREW BROKE WHEN TRYING TO PULL IT OUT WITH THE SCREWDRIVER. WHEN THE SURGEON TRIED TO PULL OUT THE SCREW (351-90-04), WHICH WAS FIXING THE RIGHT TALAR TRIAL (351-04-01) IN PLACE, WITH THE SCREW DRIVER (351-93-01 + 351-93-02), THE SCREW BROKE. THE FORCE APPLIED WAS NOT HIGHER THAN USUAL. THE SURGEON REMOVED THE LOWER PART OF THE SCREW, WHICH WAS IN THE BONE OF THE PATIENT, WAS REMOVED WITH A SMALL PAIR OF PLIERS DURING WHICH THERE WAS A 5-15 MINUTE DELAY OF THE PROCEDURE. THERE WAS NO NEGATIVE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11938460 ↗