BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VADER PEDICLE SYSTEM, ROD

    MDR report key: 18534674 · Received January 18, 2024

    Report

    Report Number
    3006493760-2024-00002
    Event Type
    Injury
    Date Received
    January 18, 2024
    Date of Event
    December 23, 2023
    Report Date
    January 18, 2024
    Manufacturer
    ICOTEC AG
    Product Code
    NKB
    UDI-DI
    07640172551738
    PMA / PMN Number
    K222789
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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. RETRIEVED IMPLANTS NOT YET AVAILABLE FOR INVESTIGATION.

    Description of Event or Problem · 0

    A PATIENT WAS TREATED WITH THE ICOTEC PEDICLE SYSTEM (T11-L5) TOGETHER WITH AN ANTERIOR FIBULAR GRAFT STRUT IN A SURGERY ((B)(6) 2023). POST-OP, IT WAS DETECTED THAT THE TWO PEDICLE RODS HAVE BROKEN AND THE FIBULAR GRAFT STRUT WAS TILTED. NO NEUROLOGICAL COMPROMISE WAS NOTED. A REVISION SURGERY WAS PERFORMED ON THE (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1627392 VADER PEDICLE SYSTEM, ROD VADER PEDICLE SYSTEM NKB ICOTEC AG 16-60-2MC30-3 22/01 07640172551738

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention