BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DANEK PLATE AND SCREW

    MDR report key: 224150 · Received May 19, 1999

    Report

    Report Number
    1030489-1999-00064
    Event Type
    Injury
    Date Received
    May 19, 1999
    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: 10/27/1989. SOMETIME AFTER IMPLANTATION, THE PT FELL. A COUPLE OF MONTHS LATER, X-RAYS REVEALED AN UPPER BONE SCREW HAD LOOSENED AND A DEVELOPING PSEUDOARTHROSIS. REVISION SURGERY ON 05/30/1990 FOR ANTERIOR FUSION WITH ALLOGRAFT. PT COMPLAINED OF PAIN AND OTHER SYMPTOMS. REVISION SURGERY ON 02/01/1991 TO REPLACE ONLY THE LOOSE BONE SCREWS AND REPAIR PSEUDOARTHROSIS. REMAINING DEVICES NOT REPORTED TO HAVE BEEN EXPLANTED.

    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 51 YR Required Intervention