BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKING SCREWS, CROSS-PIN, DIAM.2.0X8MM, (5/PACKAG

    MDR report key: 2050836 · Received April 1, 2011

    Report

    Report Number
    8010177-2011-00099
    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

    REMOVAL OF FAILED HARDWARE FROM THE LEFT ANGLE MANDIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOCKING SCREWS, CROSS-PIN, DIAM.2.0X8MM, (5/PACKAG IMPLANT JEY STRYKER OSTEOSYNTHESIS FREIBURG NA 0

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other