BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KX+ DURAT LS INSERT SM 10MM

    MDR report key: 2447352 · Received February 8, 2012

    Report

    Report Number
    9610726-2012-00041
    Event Type
    Injury
    Date Received
    February 8, 2012
    Date of Event
    January 24, 2012
    Report Date
    January 24, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    HSX
    PMA / PMN Number
    K872735
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "PT WAS REVISED DUE TO INSTABILITY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KX+ DURAT LS INSERT SM 10MM IMPLANT HSX STRYKER ORTHOPAEDICS LIMERICK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention