BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM LCP RECONSTRUCTION PLATE 7 HOLES/98MM

    MDR report key: 1060456 · Received June 9, 2008

    Report

    Report Number
    1719045-2008-00074
    Event Type
    Injury
    Date Received
    June 9, 2008
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HRS
    PMA / PMN Number
    K000684
    Adverse Event
    Yes
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    NO INVESTIGATION COULD BE PERFORMED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. SYNTHES IS UNABLE TO DETERMINE THE MFR DATE WITHOUT A LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.5MM LCP RECONSTRUCTION PLATE 7 HOLES/98MM RECONSTRUCTION PLATES HRS SYNTHES MONUMENT NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 SCREWS