BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHARLOTTE MTP FUSION SCREW

    MDR report key: 1242593 · Received November 24, 2008

    Report

    Report Number
    1043534-2008-00331
    Event Type
    Injury
    Date Received
    November 24, 2008
    Report Date
    October 26, 2008
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC
    Product Code
    HRS
    PMA / PMN Number
    K051884
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS NOT COMPLETE. ADDITIONAL INFO HAS BEEN REQUESTED. THE EVENT DEVICE CODE IS ADDRESSED IN THE PACKAGE INSERT. TRENDS WILL BE EVALUATED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS EVENT OCCURRED IN OTHER COUNTRY.

    Description of Event or Problem · 1

    ALLEGEDLY REVISED DUE TO BROKEN PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHARLOTTE MTP FUSION SCREW HRS WRIGHT MEDICAL TECHNOLOGY, INC NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Hospitalization| R