BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DANEK PLATE AND SCREW

    MDR report key: 226524 · Received June 4, 1999

    Report

    Report Number
    1030489-1999-00081
    Event Type
    Injury
    Date Received
    June 4, 1999
    Date of Event
    July 28, 1993
    Report Date
    May 7, 1999
    Manufacturer
    SOFAMOR DANEK MANUFACTURING
    Product Code
    JDN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IMPLANT DATE: 1989. REVISION SURGERY ON 11/07/1991 TO REPAIR A PSEUDOMENINGOCELE. IT WAS NOTED THAT THE DEVICE WAS SOLID. PATIENT WAS IN A MVA AND INJURED LOWER BACK. REVISION SURGERY ON 07/28/1993 IN WHICH DEVICE WAS REMOVED FROM THE RIGHT SIDE. IT WAS NOTED THAT FUSION WAS STABLE. THE REST OF THE IMPLANTS HAVE NOT BEEN REPORTED TO BE EXPLANTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention