BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERFUSE S INTERVERTEBRAL BODY FUSION DEVICE

    MDR report key: 5212196 · Received November 9, 2015

    Report

    Report Number
    3007617183-2015-00007
    Event Type
    Injury
    Date Received
    November 9, 2015
    Date of Event
    October 12, 2015
    Report Date
    November 9, 2015
    Manufacturer
    VERTEBRAL TECHNOLOGIES, INC.
    Product Code
    MAX
    UDI-DI
    00819475010090
    PMA / PMN Number
    K093675
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A REGULAR 6 WEEK POST-OP FOLLOW-UP VISIT ON (B)(6), 2015, AN X-RAY REVEALED A MODULE MIGRATION. THE PATIENT WAS ASYMPTOMATIC, WITH NO NEUROLOGIC SYMPTOMS. SURGERY WAS PERFORMED ON (B)(6), 2015 TO REMOVE THE MIGRATED MODULE (A "C" MODULE). THE REMAINING CONSTRUCT WAS INTACT AND NO ADDITIONAL ACTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742077 INTERFUSE S INTERVERTEBRAL BODY FUSION DEVICE INTERVERTEBRAL BODY FUSION DEVICE MAX VERTEBRAL TECHNOLOGIES, INC. 9076-09-20-5 141222-01 00819475010090

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention MEDTRONIC SOLERA 4.75MM SCREWS