BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3-D PALTE, CURVED, PROFILE HEIGHT 1.5MM 5X2 HOLE

    MDR report key: 2063804 · Received April 15, 2011

    Report

    Report Number
    8010177-2011-00120
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    March 24, 2011
    Report Date
    March 24, 2011
    Manufacturer
    STRYKER OSTEOSYNTHESIS FREIBURG
    Product Code
    JEY
    PMA / PMN Number
    K014263
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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

    PATIENT HAD REVISION SURGERY REMOVING PLATE AND SCREWS DUE TO AN UNRELATED INFECTION IN THE LOCAL AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3-D PALTE, CURVED, PROFILE HEIGHT 1.5MM 5X2 HOLE IMPLANT JEY STRYKER OSTEOSYNTHESIS FREIBURG NA 0

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other