BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHOENIX TIBIAL NAIL SYSTEM

    MDR report key: 1870049 · Received October 15, 2010

    Report

    Report Number
    2242816-2010-00145
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    September 24, 2010
    Report Date
    September 24, 2010
    Manufacturer
    EBI, LLC
    Product Code
    HSB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MEASURING GAUGE MEASURED INCORRECT NAIL LENGTH. A NAIL WAS PLACED AND REMOVED AS IT WAS THE INCORRECT SIZE. A SECOND NAIL OF CORRECT SIZE WAS REPLACED. PATIENT OUTCOME: NO ADVERSE EFFECT REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHOENIX TIBIAL NAIL SYSTEM TELESCOPING NAIL MEASURNG GAUGE HSB EBI, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1