BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE SCREWS, CROSS-PIN, DIAM. 2.0X4MM, (5/PACKAGE)

    MDR report key: 1971461 · Received January 21, 2011

    Report

    Report Number
    8010177-2011-00014
    Event Type
    Injury
    Date Received
    January 21, 2011
    Date of Event
    December 29, 2010
    Report Date
    December 29, 2010
    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 RETURNED FOR EVALUATION. INTERNAL INVESTIGATION IN PROCESS.

    Description of Event or Problem · 1

    PER SALES REP THE SURGEON REMOVED THE PLATES AND SCREWS BECAUSE THE PATIENT HAD AN INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BONE SCREWS, CROSS-PIN, DIAM. 2.0X4MM, (5/PACKAGE) IMPLANT JEY STRYKER OSTEOSYNTHESIS FREIBURG NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention