BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPEDIUM SINGLE INNIE SET SCREW

    MDR report key: 2011560 · Received March 7, 2011

    Report

    Report Number
    1526439-2011-00035
    Event Type
    Injury
    Date Received
    March 7, 2011
    Date of Event
    February 1, 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
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY SPINE HAS REQUESTED RETURN OF THE DEVICE FOR EVAL. A FOLLOW UP REPORT WILL BE SUBMITTED UPON RECEIPT OF THE DEVICE AND COMPLETION OF THE EVAL.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THAT THREADS TORE AWAY FROM THE SET SCREW DURING INSERTION INTO A PEDICLE SCREW. THE DEVICE WAS IMPLANTED AND IT WAS REPORTED THAT SURGICAL INTERVENTION WAS REQUIRED APPROX ONE WEEK LATER AS THE HARDWARE IS REPORTED TO HAVE FAILED. THE REPORTED FAILURE IS BELIEVED TO BE RELATED TO THE TEARING OF THE SET SCREW THREADS BUT NO DETAILS HAVE BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPEDIUM SINGLE INNIE SET SCREW SPINAL FIXATION DEVICE NKB DEPUY SPINE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention