BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STATAK SOFT TISSUE ATTACHMENT DEVICE DRIVER

    MDR report key: 1915236 · Received November 2, 2010

    Report

    Report Number
    1822565-2010-01054
    Event Type
    Malfunction
    Date Received
    November 2, 2010
    Date of Event
    September 22, 2010
    Report Date
    October 5, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    MBI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS REC'D FROM A FOREIGN SOURCE WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE STATAK DRIVER FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STATAK SOFT TISSUE ATTACHMENT DEVICE DRIVER TRAUMA PROSTHESIS MBI ZIMMER, INC. BBF10340

    Patients

    Seq Age Sex Outcome Treatment
    1