BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.5 HEX DRIVER, AO MALE QC

    MDR report key: 23213631 · Received October 3, 2025

    Report

    Report Number
    3009051471-2025-00018
    Event Type
    Malfunction
    Date Received
    October 3, 2025
    Date of Event
    September 5, 2025
    Report Date
    October 3, 2025
    Manufacturer
    CTL MEDICAL CORPORATION
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ENGINEERING EVALUATION: AFTER VISUAL INSPECTION, IT IS APPARENT THAT THE SUBJECT DRIVER WAS NOT FULLY SEATED WITHIN THE MATING VAN GOGH SCREW WHEN THE DRIVER TIP SHEARED. THE FULL ENGAGEMENT OF THE HEX DRIVER TIP IS AT A LENGTH OF ABOUT 2.5MM FROM THE DISTAL END, WHILE THE SUBJECT PART SHEARED ABOUT THE CENTER OF THE BALL-RETENTION FEATURE (ABOUT 1.1MM FROM THE DISTAL END). OVERALL ROOT CAUSE FOR THE LACK OF DRIVER TIP ENGAGEMENT IS MISUSE/ABUSE.

    Description of Event or Problem · 0

    A SCREW DRIVER WAS BEING USED TO INSERT A SCREW INTO THE VERTEBRAL BODY THROUGH THE SCREW HOLE ON AN ANTERIOR CERVICAL PLATE. WHEN INSERTING THE SCREW, THE TIP OF THE DRIVER BROKE OFF IN THE HEAD OF THE SCREW. A NERVE HOOK AND PITUITARY RONGEUR WERE USED TO PULL THE TIP OF THE DRIVER OUT OF THE SCREW. THE SURGERY WAS DELAYED A FEW MINUTES TO REMOVE THE DRIVER TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236186 2.5 HEX DRIVER, AO MALE QC SCREW DRIVER HXX CTL MEDICAL CORPORATION 100.7625 BJQAD

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown