BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NI

    MDR report key: 1051197 · Received May 22, 2008

    Report

    Report Number
    2520274-2008-00041
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Report Date
    May 2, 2008
    Manufacturer
    SYNTHES (USA)
    Product Code
    KWQ
    PMA / PMN Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE CURRENTLY REMAINS IN THE PT. SYNTHES IS UNABLE TO DETERMINE THE MANUFACTURE SITE OR THE MANUFACTURE DATE WITHOUT A LOT NUMBER. SYNTHES IS UNABLE TO DETERMINE A 510(K) # WITHOUT A PART NUMBER. NO INVESTIGATION COULD BE PERFORMED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED.

    Description of Event or Problem · 1

    A PT WAS BEING TREATED FOR A DEFORMITY. HE HAD AT LEAST ONE VERTEBRAL SEGMENT CORRECTION WITH A PARTIAL OSTEOTOMY AND WAS IMPLANTED WITH A VAS3 CONSTRUCT. THE VAS3 SCREWS LOOSENED FROM THE ROD AND THE LUMBAR CONSTRUCT LOOSENED. ALL IMPLANTS CURRENTLY REMAIN IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NI NI KWQ SYNTHES (USA) NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR