NA 206.024Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982147271), received between Dec 4, 2023 and Dec 4, 2023 — 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.

• MalfunctionDec 4, 2023Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON NOVEMBER 10, 2023 A SCREW BROKE INTRAOPERATIVELY. AS THE SURGEON WAS PUTTING THE SCREW IN TORQUE WITH THE HELP OF SCREWDRIVER THE SCREW HEAD BROKE OFF THE SCREW. THE SCREW SHAFT REMAINS IN THE PATIENT, THERE IS NO ADVERSE EVENT TO THE PATIENT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY IN SURGERY. IT WAS NOTED THE PATIENT IS DOING WELL AND THE EVENT DID NOT CHANGE THE PATIENT¿S OUTCOME. THIS REPORT IS FOR 4.0 CANCELLOUS BONE SCREW FULLY THRD/24 FOR (B)(4).

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18255558 ↗