BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERFUSE S INTERVERTEBRAL BODY FUSION DEVICE

    MDR report key: 4848193 · Received June 11, 2015

    Report

    Report Number
    3007617183-2015-00006
    Event Type
    Malfunction
    Date Received
    June 11, 2015
    Date of Event
    May 12, 2015
    Report Date
    May 13, 2015
    Manufacturer
    VERTEBRAL TECHNOLOGIES INC.
    Product Code
    MAX
    PMA / PMN Number
    K091988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHOTOGRAPHS OF THE SUSPECT DEVICE WERE REVIEWED. FROM THE PHOTOGRAPHS, IT APPEARS THE ENGAGEMENT FEATURE WAS SHEARED OFF BY A SHARP OBJECT. THE MANUFACTURING RECORD WAS REVIEWED AND ALL DEVICES PASSED THE ENGAGEMENT TESTING, SO THE ENGAGEMENT FEATURE WAS PRESENT AT THE TIME OF THE ENGAGEMENT TESTING. THE ASSEMBLY AND PACKAGING PROCESSES WERE REVIEWED AND THERE ARE NO PROCESSES PERFORMED AFTER THE ENGAGEMENT TESTING THAT COULD RESULT IN THE ENGAGEMENT FEATURE BEING SHEARED OFF.

    Description of Event or Problem · 1

    DURING THE IMPLANTATION OF AN INTERFUSE S INTERVERTEBRAL BODY FUSION DEVICE, ONE OF THE FOUR MODULES WOULD NOT ENGAGE WITH THE ADJACENT MODULE. THE SURGEON DECIDED TO USE THE SUSPECT MODULE, AS IT WAS THE SECOND OF THE FOUR MODULES AND HE FELT THE PHYSICAL STRUCTURES OF THE DISC SPACE WOULD HOLD THE MODULE IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380750 INTERFUSE S INTERVERTEBRAL BODY FUSION DEVICE INTERVERTEBRAL BODY FUSION DEVICE MAX VERTEBRAL TECHNOLOGIES INC. 9076-12-20-5 140505-01

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR