BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERFUSE INTERVERTEBRAL BODY FUSION SYSTEM

    MDR report key: 2651236 · Received May 19, 2009

    Report

    Report Number
    3007617183-2009-00002
    Event Type
    Injury
    Date Received
    May 19, 2009
    Date of Event
    April 16, 2009
    Report Date
    April 22, 2009
    Manufacturer
    VERTEBRAL TECHNOLOGIES INC.
    Product Code
    MAX
    PMA / PMN Number
    K080673
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BEING THIS IS A TWO LEVEL CASE, THERE WERE ACTUALLY TWO DEVICES OF THE SAME MODEL AND CATALOG NUMBERS IMPLANTED INTO THE PT. EACH OF THE TWO DEVICES HAD A UNIQUE LOT NUMBER. INFO ON ONE OF THE LOTS IS ALREADY REFERENCED ON THE FORM. INFO ON THE OTHER LOT IS AS FOLLOWS: LOT #: 090323-03, EXP DATE: 9/30/2009, DEVICE MANUFACTURE DATE: 3/2009. THIS ADD'L INFO IS BEING PROVIDED BEING THE LOT NUMBER OF THE REMOVED DEVICE CAN'T BE DETERMINED BEING THE DEVICE WAS DISCARDED BY THE PHYSICIAN.

    Description of Event or Problem · 1

    THIS WAS A TWO LEVEL CASE AT THE L4 - 5 AND L5 - S1 LOCATIONS. ON (B)(6) 2009, THE PT REPORTED SEVERE LEG PAIN. THE SURGEON PRESCRIBED MEDRAL DOSE PACK BUT HAD TO SURGICALLY INTERVENE. ON (B)(6) 2009, THE SURGEON FOUND TWO OF THE FOUR MODULES PROTRUDING OUT OF THE DISC SPACE AT THE L5 - S1 LOCATION. ALL FOUR SEGMENTS WERE SURGICALLY REMOVED FROM THE DISC SPACE. ONE OF THE MODULES HAD A 1 - 2 MM TAIL REMAINING ON THE POSTERIOR END. THE MODULES AT THE L4 - 5 LOCATION WERE FOUND TO BE INTACT AND WERE NOT REVISED. POST-OP, THE PT REPORTED THAT ALL LEG PAIN HAD SUBSIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERFUSE INTERVERTEBRAL BODY FUSION SYSTEM MAX VERTEBRAL TECHNOLOGIES INC. 9076-8-20-0 090112-01

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R