BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD SPINAL FIXATION SYSTEM

    MDR report key: 253553 · Received December 8, 1999

    Report

    Report Number
    1030489-1999-00189
    Event Type
    Injury
    Date Received
    December 8, 1999
    Date of Event
    May 6, 1991
    Report Date
    November 8, 1999
    Manufacturer
    SOFAMOR DANEK EUROPE
    Product Code
    KWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IMPLANT DATE: 1991. POST OPERATIVE X-RAYS REVEAL A LOOSE ROD. REVISION SURGERY IN 1991 TO REPAIR CONSTRUCT. X-RAYS TAKEN ON 9/19/1991 REVEAL A "DISPLACED" ROD. REVISION SURGERY 1991 TO REMOVE THE UPPER LEVEL OF THE CONSTRUCT. X-RAYS TAKEN ON 12/3/1991 SHOW A "LOOSENING" OF A SCREW. REVISION SURGERY IN 1992 TO REPLACE DEVICE AND REPAIR PSEUDOARTHROSIS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention