BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC SOFAMOR DANEK MEDICAL INC

    MDR report key: 304924 · Received November 14, 2000

    Report

    Report Number
    MW1020403
    Event Type
    Injury
    Date Received
    November 14, 2000
    Date of Event
    November 6, 2000
    Report Date
    November 14, 2000
    Manufacturer
    MEDTRONIC SOFAMOR DANEK MEDICAL INC
    Product Code
    MCV
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PEDICLE SPINAL SCREW BROKE AND WAS REMOVED FROM THE PT DUE TO A NON-UNION OF SPINAL FUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC SOFAMOR DANEK MEDICAL INC PEDICLE SPINAL SCREW MCV MEDTRONIC SOFAMOR DANEK MEDICAL INC DANEK 3D *

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization