BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERFUSE T INTERVERTEBRAL BODY FUSION DEVICE

    MDR report key: 3954819 · Received July 17, 2014

    Report

    Report Number
    3007617183-2014-00002
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    June 25, 2014
    Report Date
    July 17, 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) REMOVED THE IMPLANT ON (B)(6) 2014. THIS WAS A 8 MM (HEIGHT) IMPLANT. THEN HE REASSESSED THE SIZE OF THE DISC SPACE AND IMPLANTED A 13 MM (HEIGHT) PEEK BULLET IMPLANT FROM ANOTHER COMPANY.

    Description of Event or Problem · 1

    THE PT HAD BEEN IN CONSIDERABLE PAIN AND IMAGING REVEALED THAT THE C-MODULE OF THE DEVICE HAD BECOME DISENGAGED AND HAD MIGRATED OUT OF THE DISC SPACE. THIS PROMPTED THE SURGEON TO SCHEDULE THE DEVICE REMOVAL. THE WHOLE DEVICE WAS EXPLANTED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420038 INTERFUSE T INTERVERTEBRAL BODY FUSION DEVICE INTERVERTEBRAL BODY FUSION DEVICE MAX VERTEBRAL TECHNOLOGIES INC. 9091-08-20-10-Q 131014-11

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention