BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE SCREWS, CROSS-PIN, SELF-TAPPING, DIAM.1.2X4MM

    MDR report key: 2063792 · Received April 15, 2011

    Report

    Report Number
    8010177-2011-00122
    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
    K022185
    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

    THE PLATE AND 6 SCREWS WERE REMOVED FROM THE PATIENT IN ORDER TO CLEAN AND DEBRIDE THE AREA THAT HAD BECOME INFECTED. THE SURGEON STATES THAT THE INFECTION WAS NOT DUE TO THE IMPLANTS, BUT THEY HAD TO BE REMOVED IN ORDER TO CLEAN THE INFECTED AREA PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BONE SCREWS, CROSS-PIN, SELF-TAPPING, DIAM.1.2X4MM IMPLANT JEY STRYKER OSTEOSYNTHESIS FREIBURG NA 0

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other