BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VARIABLE ANGLE SCREW

    MDR report key: 200496 · Received December 3, 1998

    Report

    Report Number
    1030489-1998-00089
    Event Type
    Injury
    Date Received
    December 3, 1998
    Date of Event
    June 20, 1994
    Report Date
    December 3, 1998
    Manufacturer
    SOFAMOR DANEK MANUFACTURING
    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

    THE DEVICE WAS IMPLANTED ON 06/15/1992 AS PART OF A SPINAL FIXATION SYSTEM. REVISION SURGERY WAS PERFORMED ON 06/20/1994 TO REMOVE INSTRUMENTATION DUE TO PSEUDOARTHROSIS. THE DEVICE WAS FOUND TO BE BROKEN. ONE HALF OF THE BROKEN FRAGMENT REMAINED IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VARIABLE ANGLE SCREW Implant BONE SCREW KWP SOFAMOR DANEK MANUFACTURING NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention