BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINAL SYSTEM

    MDR report key: 8301543 · Received February 1, 2019

    Report

    Report Number
    MW5083677
    Event Type
    Injury
    Date Received
    February 1, 2019
    Report Date
    January 25, 2019
    Manufacturer
    UNK
    Product Code
    PWG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    SPINE SURGERY (METAL RODS, METAL CAGES, SCREWS, ARTIFICIAL IMPLANTS) FAILURE COMPLETELY WITHOUT MEDICAL RELIEF OR RESOLUTION. MEDICATIONS ARE NECESSARY AND PERMANENT AND/OR PERMANENT PAIN TREATMENTS DAILY. EXTREME DIFFICULTY WITH PHYSICAL MOVEMENT. ASSISTANCE NEEDED WITH THIS QUESTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91502 SPINAL SYSTEM APPLICANCE, FIXATION, SPINAL PWG UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| O| S