BEUDAMED
    FDA Adverse Event Summary report: N

    ENSPIRE FLEX

    MDR report key: 3151821 · Received June 3, 2013

    Report

    Report Number
    MW5030457
    Date Received
    June 3, 2013
    Date of Event
    March 4, 2013
    Report Date
    June 3, 2013
    Manufacturer
    SPINE VIEW, INC.
    Product Code
    HRX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN USING A SPINE VIEW, INC. DISC REMOVAL DEVICE, THE ANNULUS FIBROSUS WAS BREACHED AND THE ILIAC ARTERY WAS DAMAGED. THIS CAUSED A SUDDEN, PRECIPITOUS LOSS OF BLOOD AND BLOOD PRESSURE. WE HAD TO CLOSE THE BACK OF THE PT AND HAVE A GENERAL SURGEON REPAIR THE ARTERY THROUGH AN ABDOMINAL EXPLORATION. THE PT HAS SURVIVED. WHEN I WAS DETAILED ON THIS PRODUCT, I SPECIFICALLY ASKED WHETHER OR NOT THIS COMPLICATION TOLD NO, AND THAT FURTHERMORE THAT IT HAD NEVER HAPPENED. SINCE THE INJURY HAS BEEN NOTED HERE, I HAVE BEEN INFORMED BY ADD'L INDIVIDUALS IN THAT COMPANY THAT THERE HAVE BEEN "(B)(6) THAT WE KNOW OF IN (B)(6) CASES". MY UNDERSTANDING IS THAT THIS DEVICE WAS PUT THROUGH THE FDA ON A 510K. PLEASE CONSIDER ASKING FOR FORMAL CLINICAL TRIALS TO ASSESS SAFETY. REASON FOR USE: LUMBAR SPONDYLOLISTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242609 ENSPIRE FLEX ENSPIRE FLEX HRX SPINE VIEW, INC. 20120702-01FG

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| L| R