BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTVIEW CERVICAL PLATING SYSTEM

    MDR report key: 2211410 · Received August 8, 2011

    Report

    Report Number
    3003855635-2011-00002
    Event Type
    Injury
    Date Received
    August 8, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 28, 2011
    Manufacturer
    ATLAS SPINE INC.
    Product Code
    KWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L LOT #: 01193.

    Description of Event or Problem · 1

    RECEIVED EMAIL ON (B)(6) 2011 REQUESTING THE FOLLOWING: PLEASE FORWARD A PRODUCT EXPERIENCE FORM. SURGEON REMOVED A PLATE ON FRIDAY. DETAILS LEADING UP TO THE DEVICE FAILURE. PERFORMED A 1 LEVEL CORPECTOMY. THE DISTAL END OF THE PLATE WAS PROUD. SURGEON CONFIRMED HE WAS OK WITH IT BEING PROUD AS THE ANATOMY OF THE SPINE AND THE POSITION OF THE CORPECTOMY IMPLANT. DETAILS CONCERNING DEVICE FAILURE: SURGEON STATED THAT THE CORPECTOMY IMPLANT HAD MOVED SLIGHTLY ONCE PT WAS AMBULATORY. THE LOAD ON THE CONSTRUCT BEING A 1 LEVEL CORPECTOMY DID NOT CONCERN HIM. IF IT WAS A 2 LEVEL PERHAPS. HIS CONCERN IS THAT THE LOCKING MECHANISM ON THE PLATE DISTALLY WAS PARTIALLY UNLOCKED. WHEN IMPLANT WAS REMOVED, THE LOCKING TAB WAS PARTIALLY UNLOCKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERTVIEW CERVICAL PLATING SYSTEM NONE KWQ ATLAS SPINE INC. 70002-036 06222

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention