BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VADER PEDICLE SYSTEM, NUT SCREW

    MDR report key: 22802769 · Received August 14, 2025

    Report

    Report Number
    3006493760-2025-00003
    Event Type
    Injury
    Date Received
    August 14, 2025
    Date of Event
    July 24, 2025
    Report Date
    August 14, 2025
    Manufacturer
    ICOTEC AG
    Product Code
    NKB
    PMA / PMN Number
    K232628
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION OF HISTORICAL ADVERSE EVENT DATA DETERMINED THAT ICOTEC HAS BECOME AWARE OF FOUR SIMILAR EVENTS WITH ITS PEDICLE SYSTEM TO DATE. AT THE CURRENT STATE NO INVESTIGATION CAN BE PERFORMED AS THE LOT NUMBER OF THE DEVICE IS UNKNOWN AND NO PICTURES WERE PROVIDED TO THE MANUFACTURER. THE HOSPITAL WAS REQUESTED TO RETURN THE RETRIEVED PEDICLE SCREW AND NUT SCREW TO ICOTEC FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    A PATIENT IN SWITZERLAND WAS TREATED WITH AN ICOTEC PEDICLE SCREW SYSTEM (10 PEDICLE SCREWS, 10 NUT SCREWS, 2 PEDICLE RODS) IN 2023. THE PATIENT NOTICED INCREASING PAIN. A REVISION SURGERY WAS PERFORMED ((B)(6) 2025). DURING THE REVISION SURGERY IT WAS NOTICED THAT ONE PEDICLE SCREW HAS BECOME LOOSE IN THE BONE AND THE NUT SCREW USED TO TIGHTEN THE ROD INTO THIS PEDICLE SCREW'S HEAD HAS BECOME LOOSE. THE ONE CONCERNED PEDICLE SCREW WAS REMOVED. THE SURGEON DECIDED TO NOT REPLACE THIS PEDICLE SCREW AND THE SURGERY WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782927 VADER PEDICLE SYSTEM, NUT SCREW VADER PEDICLE SYSTEM, NUT SCREW NKB ICOTEC AG 16-57-41000 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention