BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.7MM X 10MM LKG HEXALOBE COCR SCREW

    MDR report key: 20995385 · Received December 20, 2024

    Report

    Report Number
    3025141-2024-00759
    Event Type
    Malfunction
    Date Received
    December 20, 2024
    Date of Event
    December 5, 2024
    Report Date
    December 20, 2024
    Manufacturer
    ACUMED, LLC
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED 2.7MM X 10MM LKG HEXALOBE COCR SCREW WAS NOT RETURNED FOR EVALUATION. ADDITIONALLY, MANUFACTURING AND INSPECTION RECORDS COULD NOT BE REVIEWED AS THE 2.7MM X 10MM LKG HEXALOBE COCR SCREW (PART NUMBER 3060-27010) BATCH/LOT NUMBER IS UNKNOWN. BASED ON THE INFORMATION RECEIVED, THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    (REPORT 3 OF 3) IT WAS REPORTED DURING SURGERY THAT A T8 DRIVER TIP BROKE WHILE USING COCR SCREWS. AN ATTEMPT TO USE A 2ND T8 DRIVER RESULTED IN THE THREADS ON THE DRIVER TIP WARPING AND NOT INTERFACING PROPERLY WITH THE COCR SCREW. THE SURGERY WAS COMPLETED WITH A 3RD BACKUP DEVICE WITH NO DELAY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. THERE ARE 3 RELATED REPORT NUMBERS FOR THIS EVENT 3025141-2024-00758 AND 3025141-2024-00766.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2328668 2.7MM X 10MM LKG HEXALOBE COCR SCREW SCREW, FIXATION, BONE HWC ACUMED, LLC 3060-27010

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown