BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VADER® PEDICLE SYSTEM

    MDR report key: 25344876 · Received May 31, 2026

    Report

    Report Number
    3012602431-2026-00047
    Event Type
    Injury
    Date Received
    May 31, 2026
    Date of Event
    February 11, 2026
    Report Date
    May 31, 2026
    Manufacturer
    ICOTEC AG
    Product Code
    NKB
    UDI-DI
    07640140431994
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO INFORMATION REGARDING A POTENTIAL CAUSE HAS BEEN RECEIVED FROM THE HEALTH PROFESSIONAL. ICOTEC ATTEMPTED TO OBTAIN THE RETRIEVED DEVICES FOR INVESTIGATION. TO DATE, THESE HAVE NOT BEEN MADE AVAILABLE. ANALYSIS OF THE RELEVANT PRODUCTION RECORDS OF THE DEVICES DID NOT IDENTIFY ANY ANAMOLIES THAT COULD BE A CAUSE OF THE EVENT. INVESTIGATION OF HISTORICAL ADVERSE EVENT DATA DETERMINED THAT ICOTEC HAS BECOME AWARE OF FIVE SIMILAR EVENTS WITH ITS PEDICLE SYSTEM TO DATE. THE TORQUE WRENCH USED IN INITIAL SURGERY FOR FINAL TIGHTENING THE NUT SCREWS COULD BE TESTED. IT IS WITHIN ITS SPECIFICATIONS AND FUNCTIONS AS INTENDED. IT CAN THEREFORE BE CONCLUDED THAT THE TORQUE WRENCH DID NOT CAUSE THE ADVERSE EVENT. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION OF THE CAUSE OF THIS EVENT. BASED ON THE INFORMATION AVAILABLE, NO CORRECTIVE ACTIONS ARE PROPOSED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN. DATA RELATING TO MANUFACTURING DATE IS NOT ON THE LABEL AS UDI-PI.

    Description of Event or Problem · 0

    MFR REPORT #: 3006493760-2026-00001. A PATIENT WAS IMPLANTED WITH AN ICOTEC PEDICLE SCREW SYSTEM ((B)(6) 2025). POST-SURGERY THREE NUT SCREWS (SET SCREWS) LOOSENED (EXACT DATE WERE NOT REPORTED). X-RAY IMAGING SHOWS THAT THE PEDICLE SYSTEM WAS USED TOGETHER WITH TWO ILIAC SCREWS (FROM AN UNKNOWN MANUFACTURER). A REVISION SURGERY WAS PERFORMED AND IMPLANTS WERE REPLACED ((B)(6) 2026).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352591 VADER® PEDICLE SYSTEM VADER® PEDICLE SYSTEM, NUT SCREW, PRODUCT CODE: NKB NKB ICOTEC AG 24/01, 24/05 07640140431994

    Patients

    Seq Age Sex Outcome Treatment
    1