BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHOENIX INSTRUMENTS

    MDR report key: 1922332 · Received December 13, 2010

    Report

    Report Number
    2242816-2010-00187
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    November 15, 2010
    Report Date
    November 15, 2010
    Manufacturer
    EBI, LLC
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE, THE TIP OF THE DRIVER FRACTURED AND REMAINS EMBEDDED IN THE IMPLANTED END CAP.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 INSTRUMENTS 3.5MM INSERTER CONNECTOR, SHORT LXH EBI, LLC 90227192

    Patients

    Seq Age Sex Outcome Treatment
    1