BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINELINK II

    MDR report key: 494425 · Received November 4, 2003

    Report

    Report Number
    2242816-2003-00014
    Event Type
    Malfunction
    Date Received
    November 4, 2003
    Date of Event
    October 2, 2003
    Manufacturer
    EBI, L.P.
    Product Code
    KWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DUR5ING A SCHEDULED FOLLOW-UP VISIT X-RAYS REVEALED A BROKEN PEDICLE SCREW. MD DECIDED TO REMOVE THE COMPONENTS. NO OTHER HARDWARE WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPINELINK II SPINAL FIXATION KWQ EBI, L.P. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention