BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EBI OPTILOCK PERIARTICULAR PLATING SYSTEM

    MDR report key: 1162903 · Received September 18, 2008

    Report

    Report Number
    2242816-2008-00128
    Event Type
    Malfunction
    Date Received
    September 18, 2008
    Date of Event
    July 10, 2008
    Report Date
    September 16, 2008
    Manufacturer
    EBI, L.P.
    Product Code
    HRS
    PMA / PMN Number
    K061098
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FEMORAL PLATE RECEIVED WAS OF THE WRONG ORIENTATION. THE SURGEON DID NOT USE THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EBI OPTILOCK PERIARTICULAR PLATING SYSTEM PLATE, FIXATION, BONE HRS EBI, L.P. 380138

    Patients

    Seq Age Sex Outcome Treatment
    1