BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABGII MODULAR SHORT NECK

    MDR report key: 2821396 · Received October 23, 2012

    Report

    Report Number
    9616680-2012-00913
    Event Type
    Injury
    Date Received
    October 23, 2012
    Date of Event
    September 29, 2012
    Report Date
    September 29, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    K092406
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. THIS IS THE SAME PATIENT/EVENT AS MFR # 9616680-2012-00912.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COMPONENTS WERE EXPLANTED DUE TO ADVERSE LOCAL TISSUE REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABGII MODULAR SHORT NECK IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA G3022807

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other| R