BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAXX XD

    MDR report key: 3807201 · Received May 1, 2014

    Report

    Report Number
    3807201
    Event Type
    Malfunction
    Date Received
    May 1, 2014
    Date of Event
    February 27, 2014
    Report Date
    May 1, 2014
    Manufacturer
    SPINE WAVE, INC.
    Product Code
    MQP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTED INCREASED BACK PAIN AND DISCOMFORT. X-RAY STUDIES REVEALED FAILED (BROKEN) LUMBAR 4-5 INTER-BODY CAGE. NEUROSURGERY OPERATING ROOM MANAGER CONTACTED THE COMPANY REPRESENTATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261848 STAXX XD INTERVERTEBRAL FUSION DEVICE MQP SPINE WAVE, INC. * 572K08.001

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR