BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIN PLACEMENT GUIDE

    MDR report key: 1030805 · Received April 17, 2008

    Report

    Report Number
    2242816-2008-00046
    Event Type
    Malfunction
    Date Received
    April 17, 2008
    Date of Event
    February 15, 2008
    Report Date
    March 25, 2008
    Manufacturer
    EBI
    Product Code
    FZX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL COMPONENTS OF DEVICE WAS RETURNED. SEE SCANNED PAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GUIDE HAS DETACHED FROM THE HANDLE. SURGERY WAS COMPLETED. PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIN PLACEMENT GUIDE FZX EBI 15003

    Patients

    Seq Age Sex Outcome Treatment
    1