BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERFUSE S INTERVERTEBRAL BODY FUSION DEVICE

    MDR report key: 4551186 · Received February 20, 2015

    Report

    Report Number
    3007617183-2015-00005
    Event Type
    Malfunction
    Date Received
    February 20, 2015
    Date of Event
    January 1, 2011
    Report Date
    October 11, 2011
    Manufacturer
    VERTEBRAL TECHNOLOGIES INC.
    Product Code
    MAX
    PMA / PMN Number
    K093675
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT WAS INITIALLY DETERMINED TO BE NOT REPORTABLE. DURING A RECENT FDA INSPECTION, IT WAS OBSERVED THAT THE EVENT SHOULD HAVE BEEN REPORTED. THAT IS THE REASON THIS REPORT IS BEING SUBMITTED NOW, INSTEAD OF WITHIN 30 DAYS OF THE INITIAL REPORT.

    Description of Event or Problem · 1

    THE INTERFUSE S DEVICE THAT WAS IMPLANTED BY DR. (B)(6) ON (B)(6) 2011, HAS MIGRATED TO THE ANTERIOR SIDE OF THE ANNULUS. THE SURGEON HAS DECIDED AGAINST ANY MEDICAL INTERVENTION. NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123972 INTERFUSE S INTERVERTEBRAL BODY FUSION DEVICE INTERVERTEBRAL BODY FUSION DEVICE MAX VERTEBRAL TECHNOLOGIES INC. 9076-08-20-5 100308-01

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR