BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DANEK PLATE AND SCREW

    MDR report key: 226559 · Received June 4, 1999

    Report

    Report Number
    1030489-1999-00093
    Event Type
    Injury
    Date Received
    June 4, 1999
    Date of Event
    June 10, 1991
    Report Date
    May 7, 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: 1991. POST OPERATIVE EXAM RECORD STATED THERE WAS "DISPLACEMENT OF THE LOWER SACRAL SCREWS". REVISION SURGERY ON 4/13/1992 TO REPLACE THE DEVICE WHICH WAS FOUND TO BE LOOSE. A DEVICE FROM ANOTHER MFR WAS USED IN THE REVISION SURGERY.

    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 52 YR Required Intervention