BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VADER® PEDICLE SYSTEM

    MDR report key: 24843209 · Received April 10, 2026

    Report

    Report Number
    3006493760-2026-00003
    Event Type
    Injury
    Date Received
    April 10, 2026
    Date of Event
    March 11, 2026
    Report Date
    April 10, 2026
    Manufacturer
    ICOTEC AG
    Product Code
    NKB
    UDI-DI
    07640140431994
    PMA / PMN Number
    K242900
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 NUT SCREWS AND PEDICLE SCREWS DID NOT IDENTIFY ANY ANAMOLIES THAT COULD BE A CAUSE OF THE EVENT. THE TORQUE WRENCHES USED IN THE SURGERY FOR FINAL TIGHTENING THE NUT SCREWS WERE TESTED AT ICOTEC. THE INSTRUMENTS FUNCTIONED AS INTENDED. IT CAN THEREFORE BE CONCLUDED THAT THE TORQUE WRENCH WAS NOT THE ROOT CAUSE OF THE ADVERSE EVENT. THE USE OF ICOTEC PEDICLE SCREWS AND ICOTEC NUT SCREWS TOGETHER WITH A 5.5 MM DIAMETER PEDICLE ROD FROM A THIRD-PARTY MANUFACTURER (OFF-LABEL) HAS NOT BEEN TESTED AND APPROVED BY ICOTEC. 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

    A PATIENT NOTICED INCREASING PAIN WHICH LED TO A FOLLOW-UP IMAGING (DATE NOT REPORTED) WHERE IT WAS NOTICED THAT NUT SCREWS LOOSENED. A REVISION SURGERY WAS PERFORMED (B)(6) 2026). DURING THE REVISION IT WAS DETECTED THAT TWO PEDICLE SCREWS WERE BROKEN. THE SURGEON DECIDED TO REPLACE THE PEDICLE SYSTEM. EARLIER (B)(6) 2023), THE PATIENT HAD IMPLANTED AN ICOTEC PEDICLE SYSTEM WITH A REVISION ON (B)(6) 2024 (MDR NO. ON . WHERE THE SURGEON DECIDED TO IMPLANT A 5.5 MM DIAMETER PEDICLE ROD FROM A THIRD-PARTY MANUFACTURER (OFF-LABEL). DURING THIS REVISION THE ROD WAS SECURED IN THE PEDICLE SCREWS USING NEW ICOTEC NUT SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    906134 VADER® PEDICLE SYSTEM VADER® PEDICLE SYSTEM, NUT SCREW NKB ICOTEC AG 16-57-41000 NOT REPORTED 07640140431994

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention