BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KX+ DURAT STAB INSERT XS 15MM

    MDR report key: 868747 · Received June 20, 2007

    Report

    Report Number
    9610726-2007-00022
    Event Type
    Injury
    Date Received
    June 20, 2007
    Date of Event
    May 17, 2007
    Report Date
    May 17, 2007
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    HSH
    PMA / PMN Number
    K921640
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSERT DISASSEMBLE. IN 2007, PT WAS REVISED TO REPLACE THE INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KX+ DURAT STAB INSERT XS 15MM IMPLANT HSH STRYKER ORTHOPAEDICS LIMERICK NA LJ108

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Required Intervention