BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADDPLUS

    MDR report key: 8405528 · Received March 8, 2019

    Report

    Report Number
    9612420-2019-00004
    Event Type
    Injury
    Date Received
    March 8, 2019
    Date of Event
    February 7, 2019
    Report Date
    March 8, 2019
    Manufacturer
    ULRICH GMBH & CO. KG
    Product Code
    MQP
    UDI-DI
    04052536002436
    PMA / PMN Number
    K090841
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ULRICH MEDICAL GMBH (MANUFACTURER) IS SUBMITTING THIS REPORT FOR BOTH ULRICH MEDICAL GMBH AND ULRICH MEDICAL USA (IMPORTER). EXEMPTION # E2014011

    Description of Event or Problem · 0

    X-RAYS ONE WEEK POST OPP REVEALED SUPERIOR SCREWS TO BE BACKING OUT AND CAGE TO BE TILTING AWAY FROM INTENDED POSITION. REPORT 2 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197195 ADDPLUS OSMIUM SCREW MQP ULRICH GMBH & CO. KG CS 1300-14T NI 04052536002436

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention