BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLAZER

    MDR report key: 7428338 · Received April 13, 2018

    Report

    Report Number
    7428338
    Event Type
    Malfunction
    Date Received
    April 13, 2018
    Date of Event
    March 28, 2018
    Report Date
    March 29, 2018
    Manufacturer
    BENVENUE MEDICAL, INC.
    Product Code
    OCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ATTENDING, ALONG WITH A FELLOW, WERE USING THE BLAZER-C FROM BENVENUE MEDICAL IN THE FIRST LUMBAR VERTEBRAE OF THE SPINE FROM A LEFT PEDICULAR ACCESS. THE 11GA DIAMOND TIP SINGLE STEP INTRODUCER WAS ADVANCED TO THE ANTERIOR PORTION OF L1 VERTEBRAE MARRIED WITH THE 10GA WORKING CANNULA. THE 11GA DIAMOND TIP SINGLE STEP INTRODUCER WAS REMOVED AND THE BLAZER C AUGMENTATION DEVICE WAS DEPLOYED. WHILE ADVANCING THE BLAZER C'S COIL, THE KNOB SNAPPED. THE BLAZER C WAS REMOVED AND THE 10GA WORKING CANNULA WAS TO BE REMOVED. HOWEVER, UPON TRYING TO RETRIEVE THE CANNULA, IT STARTED TO UNRAVEL. THE BEVELED TIP WAS LEFT IN THE L1 VERTEBRAL BODY BUT MOST OF THE CANNULA WAS REMOVED. MANUFACTURER RESPONSE FOR BLAZER C INTRODUCER KIT, BLAZER C (PER SITE REPORTER): DO NOT HAVE FOLLOW UP FROM THE MANUFACTURER YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271252 BLAZER SPINAL CHANNELING INSTRUMENT, VERTEBROPLASTY OCJ BENVENUE MEDICAL, INC. BCN3120 17006002

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other