BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DANEK PLATE AND SCREW

    MDR report key: 224175 · Received May 19, 1999

    Report

    Report Number
    1030489-1999-00059
    Event Type
    Injury
    Date Received
    May 19, 1999
    Date of Event
    July 1, 1992
    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: 03/09/1989. PATIENT INJURED BACK ON 01/20/1992. REVISION SURGERY ON 07/01/1992 AT WHICH TIME A DISC HERNIATION WAS FOUND AT L3-4 AND A PSEUDOARTHROSIS FOUND AT L4-5. THE SCREWS AT L4-5 WERE FOUND TO BE LOOSE. HARDWARE WAS REMOVED AND REPLACED WITH THOSE OF ANOTHER MANUFACTURER.

    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 48 YR Required Intervention