BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLLYWOOD NM IMPLANT, 11MMX27MMX8MM, LORDOTIC

    MDR report key: 3855736 · Received April 21, 2014

    Report

    Report Number
    2032593-2014-00019
    Event Type
    Malfunction
    Date Received
    April 21, 2014
    Date of Event
    March 26, 2014
    Report Date
    March 28, 2014
    Manufacturer
    SEASPINE, INC.
    Product Code
    NKB
    PMA / PMN Number
    K102026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED: 'CAGE WAS BEING INSERTED INTO THE DISC SPACE. AS IT WAS BEING MALLETED IN PLACE WITH A STRAIGHT TAMP THE CAGE BROKE INTO TWO PIECES AND WAS NOT ABLE TO BE REMOVED.' (B)(6) 2014-ADDITIONAL INFORMATION WAS RECEIVED. THE CUSTOMER SAID THE HOLLYWOOD NANOMETALENE IMPLANT WAS NOT ABLE TO BE REMOVED AND WAS IMPLANTED IN THE DISC SPACE OF L5-S1 DURING A POSTERIOR LUMBAR INTERBODY FUSION (PLIF). THERE WERE NO ADVERSE CONSEQUENCES OR INJURY TO THE PATIENT REPORTED BY THE SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241457 HOLLYWOOD NM IMPLANT, 11MMX27MMX8MM, LORDOTIC HOLLYWOOD NANOMETALENE NKB SEASPINE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1