BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KONG-TL VBR SYSTEM, SCREWDRIVER FOR LOCKING SCREW

    MDR report key: 22860250 · Received August 21, 2025

    Report

    Report Number
    3006493760-2025-00004
    Event Type
    Malfunction
    Date Received
    August 21, 2025
    Date of Event
    July 18, 2025
    Report Date
    August 21, 2025
    Manufacturer
    ICOTEC AG
    Product Code
    MQP
    UDI-DI
    07640164847849
    PMA / PMN Number
    K232790
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCTION DOCUMENTATION OF THE SCREWDRIVER HAS BEEN CHECKED, NO ANOMALIES WERE DETECTED WHEN THE SCREWDRIVER WAS RELEASED TO THE MARKET. THE SCREWDRIVER HAS BEEN RETURNED FROM THE HOSPITAL. A FRACTURE PATTERN ANALYSIS HAS BEEN INITIATED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    DURING THE LOAN CONTAINER INSPECTION AT THE MANUFACTURER IT WAS NOTICED THAT THE TIP OF A SCREWDRIVER WAS BROKEN OFF. IT IS ASSUMED THAT THE FRAGMENT HAS BROKEN OFF DURING THE LAST SURGERY. IT CAN NOT BE EXCLUDED THAT THE BROKEN OFF FRAGMENT REMAINED IN THE HEAD OF THE LOCKING SCREW AND THEREFORE IN THE PATIENT'S BODY. THE SUITABILITY OF THE MATERIAL OF THE FRAGMENT (STAINLESS STEEL 1.4112) HAS NOT BEEN EVALUATED FOR LONG-TERM TISSUE/BONE CONTACT. UNDESIRABLE LOCAL OR SYSTEMIC EFFECTS CANNOT BE EXCLUDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2410876 KONG-TL VBR SYSTEM, SCREWDRIVER FOR LOCKING SCREW KONG-TL VBR SYSTEM, SCREWDRIVER FOR LOCKING SCREW MQP ICOTEC AG 44-050 23/01 07640164847849

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown