BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPEDIUM 5.50 POLYAXIAL SCREW 7.00X40MM, TI

    MDR report key: 2130459 · Received June 13, 2011

    Report

    Report Number
    1526439-2011-00100
    Event Type
    Injury
    Date Received
    June 13, 2011
    Date of Event
    May 17, 2011
    Manufacturer
    DEPUY SPINE, INC.
    Product Code
    NKB
    PMA / PMN Number
    K033901
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REMOVED PORTION OF THE SCREW WAS DISCARDED AND IS NOT AVAILABLE FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORD CANNOT BE PERFORMED AS THE DEVICE LOT CODE IS UNK. NO CONCLUSIONS CAN BE MADE AT THIS TIME. THE DEVICE IS INTENDED TO BE A TEMPORARY FIXATION DEVICE TO AID IN THE PROCESS OF FUSION. BREAKAGE CAN OCCUR DUE TO DELAYED UNION OR NON-UNION AS WELL AS WITH 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 AN EXTENSION OF AN EXISTING SPINAL CONSTRUCT, THE SCREW HEAD OF IMPLANTED S1 RIGHT SCREW BROKE OFF. REPORTS THAT IT APPEARED THAT FUSION HAD BEEN ACHIEVED AND THAT SCREW BREAKAGE OCCURRED DURING ROD REDUCTION AND DISTRACTION. THE SHAFT OF THE BROKEN SCREW REMAINS IN THE PT. THE REMOVED PORTION OF THE SCREW WAS DISCARDED BY THE CUSTOMER AND IS NOT AVAILABLE FOR EVALUATION. THE DEVICE WAS IMPLANTED IN 2010, THE EXACT DATE UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPEDIUM 5.50 POLYAXIAL SCREW 7.00X40MM, TI SPINAL FIXATION DEVICE NKB DEPUY SPINE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention