BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD SPINAL FIXATION SYSTEM

    MDR report key: 224136 · Received May 19, 1999

    Report

    Report Number
    1030489-1999-00069
    Event Type
    Injury
    Date Received
    May 19, 1999
    Date of Event
    October 16, 1991
    Report Date
    April 20, 1999
    Manufacturer
    SOFAMOR DANEK EUROPE
    Product Code
    KWP
    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: 06/1990. PT COMPLAINED OF PAIN. REVISION SURGERY ON 10/16/1991 TO REPLACE HARDWARE AND REPAIR PSEUDOARTHROSIS FOUND AT L4-5 AND L5-S1. IT WAS FOUND THAT THE RIGHT SACRAL SCREW HAD DISLODGED FROM THE ROD. DUE TO PAIN, REVISION SURGERY WAS PERFORMED AGAIN TO REMOVE DEVICE ON 10/27/1993 AT WHICH TIME IT WAS NOTED THAT THE FUSION WAS SOLID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD SPINAL FIXATION SYSTEM Implant SPINAL FIXATION SYSTEM KWP SOFAMOR DANEK EUROPE NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention