NA 214.920Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982154958), received between Jun 6, 2022 and Jun 6, 2022 — classified as 1 injury.

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.

• InjuryJun 6, 2022Break; Break

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, THE 4.5MM CORTEX SCREW SELF-TAPPING 120MM BROKE WHILE BEING INSERTED INTO THE FIBULA AND BECAME IMPOSSIBLE TO EXTRACT. THE HEAD OF THE SCREW THAT HAD NOT ENTERED THE BONE WAS CUT WITH A SAW, AND THE REST OF THE SCREW WAS LEFT INSIDE OF THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH AN UNKNOWN DELAY. THE PATIENT WAS UNDERGOING FRACTURE REDUCTION AND FIXATION. THIS REPORT IS FOR A 4.5MM CORTEX SCREW SELF-TAPPING 120MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14601639 ↗