BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COROENT XL PEEK

    MDR report key: 2771693 · Received September 28, 2012

    Report

    Report Number
    MW5027124
    Event Type
    Malfunction
    Date Received
    September 28, 2012
    Date of Event
    June 15, 2012
    Report Date
    September 28, 2012
    Manufacturer
    NUVASIVE
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT ANTERIOR PORTION OF RADICAL LUMBAR DISCECTOMY/FUSION. INSERTING THE CAGE, 8 X 8 X 50, INTO THE L1-2 SPACE, THE CAGE BROKE. AS HALF THE CAGE WAS WELL FIXED INTO THE DISK SPACE, AND THERE WAS GOOD FILLING OF THE SPACE ALONG WITH WEIGHT RESTORATION, AS MUCH OF THE BROKEN PIECES POSSIBLE WERE REMOVED. X-RAYS REVEALED EXCELLENT PLACEMENT OF THE CAGES IN THE AP AND LATERAL PLANE. SURGEON STATED THERE WOULD BE NO ADVERSE OUTCOME TO THE PT. NO SERIAL NUMBER WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COROENT XL PEEK CRATE KWQ NUVASIVE

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR