BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTLOCK HYBRID MMF PLATE, 2/P

    MDR report key: 3944872 · Received July 18, 2014

    Report

    Report Number
    0008010177-2014-00184
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    June 25, 2014
    Report Date
    June 25, 2014
    Manufacturer
    STRYKER LEIBINGER FREIBURG
    Product Code
    JEY
    PMA / PMN Number
    K122313
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED FOR EVALUATION AS IT WAS DISCARDED BY THE HOSPITAL. IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT. DEVICE DISCARDED.

    Description of Event or Problem · 1

    FOUND REMOVAL OF LEIBINGER HMMF VERY DIFFICULT AFTER 3 WEEKS DUE TO OVERGROWTH OF TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421279 SMARTLOCK HYBRID MMF PLATE, 2/P IMPLANT JEY STRYKER LEIBINGER FREIBURG

    Patients

    Seq Age Sex Outcome Treatment
    1