BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLLYWOOD NM IMPLANT, 11MMX27MMX8MM, LORDOIC

    MDR report key: 3770720 · Received February 18, 2014

    Report

    Report Number
    2032593-2014-00007
    Event Type
    Malfunction
    Date Received
    February 18, 2014
    Date of Event
    January 24, 2014
    Report Date
    January 27, 2014
    Manufacturer
    SEASPINE, INC.
    Product Code
    NKB
    PMA / PMN Number
    K102026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THIS IS THE FIRST REPORT OF TWO REPORTS CONCERNING THE SAME PT/SURGERY. THIS REPORT CONCERNS THE FIRST HOLLYWOOD NM IMPLANT, 11MMX27MMX8MM, LORDOTIC (PRODUCT ID 34-5108). IT WAS REPORTED 'THE FIRST CAGE SHATTERED UPON INSERTION, THE SECOND CAGE FELL OFF THE INSERTER COULD NOT PUT IT BACK ON THE INSERTER, HAD TO DRILL AND CUT OUT THE DISC SPACE REPLACED IT WITH PACIFICA CAGE.' ON (B)(6) 2014 ADDITIONAL INFORMATION WAS RECEIVED: THE CUSTOMER REPORTED DURING A L5-S1 TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF), THE FIRST CAGE SHATTERED UPON INSERTION WHEN THE SURGEON 'MALLETED' IT INTO PLACE. IT WAS REMOVED AND THE SURGEON ATTEMPTED TO BUT IN THE SECOND CAGE WHICH FELL OFF THE INSERTER; THE SURGEON COULD NOT PUT IT BACK ON THE INSERTER. IT GOT STUCK IN THE DISC SPACE. THE SURGEON DRILLED AND CUT OUT THE (SECOND) DEVICE IN THE DISC SPACE AND REPLACED IT WITH A PACIFICA CAGE. SURGERY WAS DELAYED 1 HOUR DUE TO THESE ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101798 HOLLYWOOD NM IMPLANT, 11MMX27MMX8MM, LORDOIC HOLLYWOOD NANOMETALENE NKB SEASPINE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1