BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VADER PEDICLE SYSTEM, SCREW, CARBON/PEEK, POLYAX., FEN., Ø 5.5 X 45 MM

    MDR report key: 23028787 · Received September 11, 2025

    Report

    Report Number
    3006493760-2025-00005
    Event Type
    Injury
    Date Received
    September 11, 2025
    Date of Event
    August 12, 2025
    Report Date
    September 11, 2025
    Manufacturer
    ICOTEC AG
    Product Code
    NKB
    UDI-DI
    07640164844671
    PMA / PMN Number
    K232628
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DATA RELATING TO MANUFACTURING DATE IS NOT ON THE LABEL AS UDI-PI. ANALYSIS OF THE RELEVANT PRODUCTION RECORDS OF THE PEDICLE SCREW DID NOT IDENTIFY ANY ANAMOLIES THAT COULD BE A CAUSE OF THE EVENT. THE HOSPITAL WAS REQUESTED TO RETURN THE RETRIEVED PEDICLE SCREWS FOR INVESTIGATION. THE IMPLANTS WILL NOT BE RETURNED AS THE PATIENT DECIDED TO KEEP THE IMPLANTS 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.

    Description of Event or Problem · 0

    A PATIENT IN SWITZERLAND WAS TREATED WITH AN ICOTEC PEDICLE SCREW SYSTEM (8 PEDICLE SCREWS). THE PATIENT NOTICED INCREASING PAIN. IMAGING REVEALED A POSSIBLE INFECTION IN THE LOCATION OF THE IMPLANTS AND LOOSENED PEDICLE SCREWS. A REVISION SURGERY WAS REQUIRED. DURING THE REVISION SURGERY (B)(6) 2025) ALL SCREWS WERE REMOVED WHEREBY ONE SCREW BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2231956 VADER PEDICLE SYSTEM, SCREW, CARBON/PEEK, POLYAX., FEN., Ø 5.5 X 45 MM VADER PEDICLE SYSTEM, SCREW, CARBON/PEEK, POLYAX., FEN., Ø 5.5 X 45 MM NKB ICOTEC AG 16-6022-55545 UNKNOWN 07640164844671

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention