USS 03.621.011Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034718101), received between Nov 23, 2020 and Nov 23, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Integrity Problem” (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.

• MalfunctionNov 23, 2020Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 DURING A PELVIS FUSION IN THE ILIUM PROCEDURE, THE TIP OF THE SCREW HOLDER BROKE OFF DURING FINAL SCREW TIGHTENING. THE FRAGMENT WAS EASILY REMOVED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS A SURGICAL DELAY OF LESS THAN THIRTY (30) MINUTES. THE PATIENT OUTCOME WAS REPORTED AS STABLE. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) CLAMP HOLDER FOR USS ILIOSACRAL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10886013 ↗