BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DANEK PLATE AND SCREW

    MDR report key: 224160 · Received May 19, 1999

    Report

    Report Number
    1030489-1999-00052
    Event Type
    Injury
    Date Received
    May 19, 1999
    Date of Event
    January 21, 1991
    Report Date
    April 20, 1999
    Manufacturer
    SOFAMOR DANEK MANUFACTURING
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IMPLANT DATE: 8/13/1990. PT EXPERIENCED PAIN. EXPLANT DATE: 1/21/1991. AT TIME OF EXPLANT A SCREW WAS NOTED TO BE LOOSE AND FUSION HAD NOT YET FULLY MATURED. AUGMENTATION OF FUSION WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DANEK PLATE AND SCREW Implant BONE PLATE AND SCREW HRS SOFAMOR DANEK MANUFACTURING NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention