BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMENDIA

    MDR report key: 7475398 · Received April 30, 2018

    Report

    Report Number
    MW5076933
    Event Type
    Malfunction
    Date Received
    April 30, 2018
    Date of Event
    March 22, 2018
    Report Date
    April 27, 2018
    Manufacturer
    SPINAL ELEMENTS
    Product Code
    MAX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE INSERTING THE INTERBODY SPACER THE INSTRUMENT USED TO PLACE THE IMPLANT BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314527 AMENDIA INTEVERTEBRAL FUSION DEVICE WITH BONEGRAFT MAX SPINAL ELEMENTS 72-06-2

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR