BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EBI TROCHANTERIC NAIL SYSTEM

    MDR report key: 1021610 · Received March 25, 2008

    Report

    Report Number
    2242816-2008-00043
    Event Type
    Malfunction
    Date Received
    March 25, 2008
    Date of Event
    February 12, 2008
    Report Date
    March 19, 2008
    Manufacturer
    EBI
    Product Code
    HSB
    PMA / PMN Number
    K050118
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NAIL WAS FOUND BROKEN AT THE TIP OF THE LAG SCREW HOLE. THIS WAS DISCOVERED UPON SCHEDULED HARDWARE REMOVAL AND WAS NOT THE REASON FOR HARDWARE REMOVAL. PT STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EBI TROCHANTERIC NAIL SYSTEM HSB EBI 209374

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR