NA 401.512.96Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982204349), received between Aug 23, 2018 and Aug 23, 2018 — 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.

• MalfunctionAug 23, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) FOR METACARPAL PROCEDURE ON (B)(6) 2018. THE SURGEON IMPLANTED A 2.4MM PLATE. AS THE SURGEON ATTEMPTED TO INSERT THE SCREW, IT WAS NOTICED THAT THE LINING OF THE SCREW WAS PEELING. THE SCREW AND THE SCREW LINING PIECES WERE REMOVED FROM THE PATIENT AND DISCARDED. A NEW SCREW WAS USED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. PATIENT WAS STABLE. CONCOMITANT DEVICE: 2.4MM PLATE (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A 2.4MM TITANIUM (TI) CORTEX SCREW SELF-TAPPING 12MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7808528 ↗