BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCORDE BUL LOR 9X11X27, 5 DG

    MDR report key: 6648073 · Received June 16, 2017

    Report

    Report Number
    1526439-2017-10470
    Event Type
    Malfunction
    Date Received
    June 16, 2017
    Date of Event
    May 23, 2017
    Report Date
    May 23, 2017
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    MAX
    PMA / PMN Number
    K081917
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A COMPLAINT INVESTIGATION WILL BE PERFORMED. THE COMPLAINT PRODUCT IS NOT AVAILABLE FOR THE INVESTIGATION. A SUPPLEMENTAL REPORT IS NOT ANTICIPATED UNLESS THE RESULTS OF THE COMPLAINT INVESTIGATION IDENTIFY A CORRECTIVE ACTION OR ADDITIONAL RELEVANT INFORMATION. SHOULD THE PRODUCT BECOME AVAILABLE, A PHYSICAL EVALUATION WILL BE CONDUCTED AND A SUPPLEMENTAL REPORT FILED WITH THE RESULTS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    A 9X11X27MM CONCORDE BULLET CAGE WAS PROPERLY LOADED ON INSERTER. SURGEON BEGAN TO INSERT CAGE INTO THE INTERBODY SPACE (L4-5). THE THREADS ON THE CAGE SEEMED TO GIVE WAY AND A VERY SMALL POSTERIOR PIECE OF THE CAGE ADJACENT TO THREADS BROKE FREE. THE SURGEON IMMEDIATELY REMOVED THE CAGE. ABSOLUTELY NO PART OF THE CAGE REMAINED - ALL PIECES OF THE CAGE & THREADS WERE CLEARLY AND THOROUGHLY REMOVED WITH NO DELAY OR HARM TO THE PATIENT.A SECOND CAGE WAS THEN PACKED WITH THE PATIENT'S BONE AND SUBSEQUENTLY INSERTED INTO DISC SPACE WITH NO ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428377 CONCORDE BUL LOR 9X11X27, 5 DG INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX DEPUY SYNTHES SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR