BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSTEO

    MDR report key: 209900 · Received March 19, 1999

    Report

    Report Number
    1020279-1999-00004
    Event Type
    Injury
    Date Received
    March 19, 1999
    Date of Event
    January 7, 1999
    Report Date
    January 13, 1999
    Manufacturer
    OSTEO AG
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE, INITIALLY IMPLANTED ON 11/21/1998 FRACTURED AND REQUIRED REVISION ON 1/7/99.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSTEO Implant BONE PLATE HRS OSTEO AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R