BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOAXIAL SCREW

    MDR report key: 2922353 · Received January 11, 2013

    Report

    Report Number
    3003853072-2013-00034
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 7, 2012
    Report Date
    December 13, 2012
    Manufacturer
    ZIMMER SPINE
    Product Code
    KWQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JO
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE ROD SLIPPED FROM THE CONSTRUCT APPROX ONE MONTH POST-OPERATIVELY. THE PT WAS REVISED. NO FURTHER INFO IS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16397 MONOAXIAL SCREW MONOAXIAL SCREW KWQ ZIMMER SPINE 046W0AN35545 E54599

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR