BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VARIABLE ANGLE SCREW

    MDR report key: 161878 · Received April 9, 1998

    Report

    Report Number
    1030489-1998-00016
    Event Type
    Injury
    Date Received
    April 9, 1998
    Date of Event
    March 9, 1994
    Report Date
    March 10, 1998
    Manufacturer
    SOFAMOR DANEK MFG
    Product Code
    MCV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS IMPLANTED ON 7/16/1993. DEVICE WAS EXPLANTED ON 3/9/94. MEDICAL RECORDS REPORT OSTEOMYELITIS AND PSEUDOARTHROSIS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention