BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EBI TROCHANTERIC NAIL SYSTEM

    MDR report key: 1014031 · Received March 14, 2008

    Report

    Report Number
    2242816-2008-00032
    Event Type
    Malfunction
    Date Received
    March 14, 2008
    Date of Event
    February 20, 2008
    Report Date
    February 29, 2008
    Manufacturer
    EBI
    Product Code
    HRS
    PMA / PMN Number
    K050118
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L CATALOG# 27962, LOT# 561105. DEVICE MANUFACTURE DATE: 02/2006.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DRIVERS BROKE DURING USE. PATIENT STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EBI TROCHANTERIC NAIL SYSTEM HRS EBI M12733-01

    Patients

    Seq Age Sex Outcome Treatment
    1