BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTRUX - PEEK VBR

    MDR report key: 4975519 · Received August 5, 2015

    Report

    Report Number
    3008524126-2015-00020
    Event Type
    Malfunction
    Date Received
    August 5, 2015
    Date of Event
    May 25, 2015
    Report Date
    September 16, 2015
    Manufacturer
    ORTHOFIX INC
    Product Code
    MQP
    PMA / PMN Number
    K060350
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INFORMATION PROVIDED STATES THAT THE LATERAL SPACER PLACED IN THE LOWER LUMBAR VERTEBRAE BROKE DURING SURGERY. THE SURGEON REMOVED PART OF THE SPACER RESULTING IN A DELAY IN THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517703 CONSTRUX - PEEK VBR CONSTRUX VBR 28MM PARALLEL LATERAL SPACER - 8MM MQP ORTHOFIX INC 45-3208 D973

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other