BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERFUSE T INTERVERTEBRAL BODY FUSION DEVICE

    MDR report key: 3896246 · Received June 12, 2014

    Report

    Report Number
    3007617183-2014-00001
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    May 19, 2014
    Report Date
    June 12, 2014
    Manufacturer
    VERTEBRAL TECHNOLOGIES INC.
    Product Code
    MAX
    PMA / PMN Number
    K110226
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DR. (B)(6) PERFORMED MEDICAL INTERVENTION ON 06/02/2014. DR. (B)(6) CONNECTED THE INSERTER TO THE C MODULE AND WAS ABLE TO MALLET THE C AND B MODULES, CONNECTING WITH THE A MODULE. ALL MODULES WERE THEN CENTERED AND COMPRESSION WAS APPLIED. THE C ARM WAS BROUGHT IN AND ALL MODULES WERE CONNECTED IN PERFECT CENTERED DISC POSITION.

    Description of Event or Problem · 1

    THE PATIENT REPORTED SIDE PAIN APPROX ONE WEEK AFTER THE INITIAL PROCEDURE. IT APPEARS THAT THE A MODULE SEPARATED FROM THE B MODULE, OR WAS NEVER CONNECTED PROPERLY DURING THE INITIAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348663 INTERFUSE T INTERVERTEBRAL BODY FUSION DEVICE INTERVERTEBRAL BODY FUSION DEVICE MAX VERTEBRAL TECHNOLOGIES INC. 9091-10-20-10-Q 130812-20/131014-15

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention