BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM PUBLIC SYMPHYSIS PLATE

    MDR report key: 1163370 · Received September 10, 2008

    Report

    Report Number
    3003506883-2008-00018
    Event Type
    Malfunction
    Date Received
    September 10, 2008
    Report Date
    July 3, 2008
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    PMA / PMN Number
    KO42377
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO INVESTIGATION COULD BE PERFORMED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED.

    Description of Event or Problem · 1

    A BROKEN SYMPHYSIS PLATE WAS REPORTED FROM (B) (6), NO ADDITIONAL INFO WAS PROVIDED. DESPITE MULTIPLE ATTEMPTS TO ELICIT ADDITIONAL INFO, NO INFO WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.5MM PUBLIC SYMPHYSIS PLATE PUBLIC SYMPHYSIS PLATE HRS SYNTHES (USA) NA 5274476

    Patients

    Seq Age Sex Outcome Treatment
    1 NI SCREWS