BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DANEK SCREW

    MDR report key: 227054 · Received June 4, 1999

    Report

    Report Number
    1030489-1999-00084
    Event Type
    Injury
    Date Received
    June 4, 1999
    Date of Event
    July 15, 1994
    Report Date
    May 7, 1999
    Manufacturer
    SOFAMOR DANEK MANUFACTURING
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IMPLANT DATE: 1993. X-RAYS TAKEN 5/23/1994 REVEALED PSEUDOARTHROSIS. EXPLANT DATE: 1994. PATIENT WAS RE-INSTRUMENTED WITH A DEVICE FROM ANOTHER MANUFACTURER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention