BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPEDIUM 5.5 MONOAXIAL SCREW 6X40MM, TI

    MDR report key: 2003615 · Received February 22, 2011

    Report

    Report Number
    1526439-2011-00017
    Event Type
    Injury
    Date Received
    February 22, 2011
    Date of Event
    December 28, 2010
    Manufacturer
    DEPUY SPINE, INC.
    Product Code
    MNH
    PMA / PMN Number
    K062174
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSIONS CAN BE MADE AT THIS TIME. DEVICE IS INTENDED TO BE A TEMPORARY FIXATION DEVICE TO AID IN THE PROCESS OF FUSION, AND BREAKAGE CAN OCCUR DUE TO DELAYED UNION OR NON-UNION, AS WELL AS CYCLICAL LOADING OF THE DEVICE OVER TIME. NOTCHES, SCRATCHES OR BENDING OF THE IMPLANT DURING THE COURSE OF SURGERY MAY ALSO CONTRIBUTE TO EARLY FAILURE. THESE PRECAUTIONS ARE STATED IN THE INSTRUCTIONS-FOR-USE (IFU) SUPPLIED WITH THE DEVICE.

    Description of Event or Problem · 1

    CONTACT REPORTS THAT DURING A SPINAL REVISION PROCEDURE A BROKEN SCREW WAS FOUND AND EXTRACTED FROM THE SITE. THE HARDWARE WAS IMPLANTED ON (B)(6), 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPEDIUM 5.5 MONOAXIAL SCREW 6X40MM, TI SPINAL FIXATION DEVICE MNH DEPUY SPINE, INC. NA AJMBLG

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention