BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON CONICAL CORE SCREW

    MDR report key: 223068 · Received May 11, 1999

    Report

    Report Number
    1030489-1999-00037
    Event Type
    Injury
    Date Received
    May 11, 1999
    Date of Event
    April 1, 1999
    Report Date
    April 12, 1999
    Manufacturer
    SOFAMOR DANEK EUROPE
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IMPLANT DATE: 01/1999. BROKEN SCREW DISCOVERED AT THE LEFT L4. REVISION SURGERY IN 04/1999 TO REPLACE SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON CONICAL CORE SCREW Implant BONE SCREW HWC SOFAMOR DANEK EUROPE NA 170288

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention