BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSTEM 12 CROSSFIRE 10 28MM

    MDR report key: 1810020 · Received August 16, 2010

    Report

    Report Number
    2249697-2010-01102
    Event Type
    Injury
    Date Received
    August 16, 2010
    Date of Event
    July 22, 2010
    Report Date
    July 22, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K993352
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFO (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. IF ADDITIONAL INFO BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "DISLOCATED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM 12 CROSSFIRE 10 28MM IMPLANT JDI STRYKER ORTHOPAEDICS MAHWAH NA 63618901

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other| R