BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VADER® PEDICLE SYSTEM

    MDR report key: 24843169 · Received April 10, 2026

    Report

    Report Number
    3006493760-2026-00004
    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
    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 PEDICLE SCREWS DID NOT IDENTIFY ANY ANAMOLIES THAT COULD BE A CAUSE OF THE 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

    A PATIENT IMPLANTED WITH AN ICOTEC PEDICLE SYSTEM (B)(6) 2023) REQUIRED A REVISION SURGERY (B)(6) 2026; LOOSENED NUT SCREWS, TWO BROKEN PEDICLE SCREWS; MDR NO. 3006493760-2026-00003). THE SURGEON DECIDED TO REPLACE THE ENTIRE SYSTEM. WHEN ATTEMPTING TO REMOVE THE OSSEOINTEGRATED PEDICLE SCREWS, SIX OF THEM BROKE. THE SURGEON DECIDED TO LEAVE THE FRACTURED SHAFTS IN PLACE AND TO EXTEND THE CONSTRUCT TO ADDITIONAL LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    905416 VADER® PEDICLE SYSTEM VADER® PEDICLE SYSTEM, SCREW, CARBON/PEEK, POLYAX., FEN. NKB ICOTEC AG NOT REPORTED NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention