BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLANTIS CANCELLOUS SCREW

    MDR report key: 204551 · Received January 4, 1999

    Report

    Report Number
    1030489-1999-00001
    Event Type
    Injury
    Date Received
    January 4, 1999
    Date of Event
    November 1, 1998
    Report Date
    December 4, 1998
    Manufacturer
    SOFAMOR DANEK MANUFACTURING
    Product Code
    KWQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IMPLANT DATE: 10/1998. CANCELLOUS SCREW BACKED OUT. EXPLANT DATE: 11/1998.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention