BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKING SCREWS, CROSS-PIN, DIAM.2.0X5MM, (5/PACKAG

    MDR report key: 2050835 · Received April 1, 2011

    Report

    Report Number
    8010177-2011-00096
    Event Type
    Injury
    Date Received
    April 1, 2011
    Date of Event
    March 9, 2011
    Report Date
    March 9, 2011
    Manufacturer
    STRYKER OSTEOSYNTHESIS FREIBURG
    Product Code
    JEY
    PMA / PMN Number
    K022185
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT AVAILABLE FOR RETURN. INVESTIGATION IN PROCESS BUT NOT YET COMPLETE.

    Description of Event or Problem · 1

    THE SCREW AND PLATE PULLED AWAY FROM THE BONE OF THE JAW. PLATE AND SCREWS WERE REMOVED. THE FRACTURED HEALED CORRECTLY AND THE HOSPITAL RETAINED PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOCKING SCREWS, CROSS-PIN, DIAM.2.0X5MM, (5/PACKAG IMPLANT JEY STRYKER OSTEOSYNTHESIS FREIBURG NA 0

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Other