BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER UNIVERSAL LOCKING RECONSTRUCT PLATE

    MDR report key: 1932187 · Received December 14, 2010

    Report

    Report Number
    1822565-2010-01352
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    November 9, 2010
    Report Date
    November 16, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A FOREIGN SOURCE WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PLATE FRACTURED DURING ABDUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER UNIVERSAL LOCKING RECONSTRUCT PLATE TRAUMA PROSTHESIS HRS ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1