BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICOTEC PEDICLE SYSTEM, NUT SCREW, TI

    MDR report key: 17842817 · Received September 29, 2023

    Report

    Report Number
    3006493760-2023-00003
    Event Type
    Injury
    Date Received
    September 29, 2023
    Date of Event
    August 21, 2023
    Report Date
    September 29, 2023
    Manufacturer
    ICOTEC AG
    Product Code
    NKB
    UDI-DI
    07640140431994
    PMA / PMN Number
    K200596
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS OF THE RELEVANT PRODUCTION RECORDS DID NOT IDENTIFY ANY ANOMALIES THAT COULD BE A CAUSE OF THE EVENT. INVESTIGATION OF HISTORICAL ADVERSE EVENT DATA DETERMINED THAT ICOTEC HAS BECOME AWARE OF ONE SIMILAR EVENT WITH ITS PEDICLE SYSTEM TO DATE.

    Description of Event or Problem · 0

    A PATIENT WAS TREATED WITH THE ICOTEC PEDICLE SYSTEM IN A SURGERY ((B)(6) 2022). DURING A POST-OP CHECK, IT WAS DETECTED THAT FOUR NUT SCREWS HAD LOOSENED. A REVISION SURGERY HAD TO BE CARRIED OUT ((B)(6) 2023). DURING THE REVISION SURGERY, IT WAS REALIZED THAT ONE PEDICLE SCREW HAD BROKEN. THE BROKEN PEDICLE SCREW WAS NOT REMOVED. THE LOOSENED NUT SCREWS WERE REVISED AND THE BROKEN SCREW REMAINED IN THE PATIENT. NO ADDITIONAL LEVEL WAS TREATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2278515 ICOTEC PEDICLE SYSTEM, NUT SCREW, TI PEDICLE SCREW SYSTEM NKB ICOTEC AG 16-57-41000 20/02 07640140431994

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention