BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M-SERIES LPB NECK, HI OFFSET +10

    MDR report key: 4176255 · Received July 25, 2014

    Report

    Report Number
    1038671-2014-00408
    Event Type
    Malfunction
    Date Received
    July 25, 2014
    Date of Event
    January 20, 2012
    Report Date
    July 23, 2014
    Manufacturer
    EXACTECH, INC.
    Product Code
    LZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ASSOCIATED WITH MDR 1038671-2012-00023.

    Description of Event or Problem · 1

    EXACTECH M-SERIES STEM AND ASSOCIATED COMPONENTS REVISED DUE TO BROKEN STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436684 M-SERIES LPB NECK, HI OFFSET +10 LPB NECK, HI OFFSET, +10 LZO EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention