BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KONG-TL VBR SYSTEM, SCREWDRIVER FOR LOCKING SCREW

    MDR report key: 15691054 · Received October 28, 2022

    Report

    Report Number
    3006493760-2022-00002
    Event Type
    Malfunction
    Date Received
    October 28, 2022
    Date of Event
    September 29, 2022
    Report Date
    October 28, 2022
    Manufacturer
    ICOTEC AG
    Product Code
    MQP
    UDI-DI
    07640164847849
    PMA / PMN Number
    K200235
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE USER HAS CONFIRMED THAT THE SURGERY WAS PERFORMED IN ACCORDANCE WITH IFU. ANALYSIS OF THE RELEVANT PRODUCTION RECORDS OF THE SCREWDRIVER DID NOT IDENTIFY ANY ANOMALIES THAT COULD BE A CAUSE OF THE EVENT. THE BROKEN SCREWDRIVER WAS RETURNED TO ICOTEC AND THE INVESTIGATION OF THE BREAKAGE HAS BEEN STARTED.

    Description of Event or Problem · 0

    WHEN TIGHTENING THE LOCKING SCREW OF THE EXPANDABLE VBR, IT WAS NOTICED THAT THE SCREWDRIVER TIP HAD BROKEN OFF. THE BROKEN OFF FRAGMENT REMAINED IN THE HEAD OF THE LOCKING SCREW. THE VBR WAS LEFT IMPLANTED AND THE SURGERY WAS COMPLETED WITHOUT FURTHER COMPLICATIONS. THE BROKEN OFF FRAGMENT REMAINED IN THE SCREW HEAD 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2725067 KONG-TL VBR SYSTEM, SCREWDRIVER FOR LOCKING SCREW Spinal vertebral body replacement device MQP ICOTEC AG 44-050 20/02 07640164847849

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other