BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DSS STABILIZATION SYSTEM

    MDR report key: 6947181 · Received October 13, 2017

    Report

    Report Number
    3005725110-2017-00006
    Event Type
    Malfunction
    Date Received
    October 13, 2017
    Date of Event
    September 12, 2017
    Report Date
    October 13, 2017
    Manufacturer
    PARADIGM SPINE GMBH
    Product Code
    NQP
    PMA / PMN Number
    K120491
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DSS REVISION SURGERY DUE TO BROKEN DSS PEDICLE SCREW IN S1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729370 DSS STABILIZATION SYSTEM POSTERIOR METAL / POLYMER SPINAL SYSTEM NQP PARADIGM SPINE GMBH DPI56045 2010006098

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention