BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVIGATOR 10MM X 26MM X 0DEG. SPACER

    MDR report key: 2152295 · Received June 23, 2011

    Report

    Report Number
    9617544-2011-00221
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 7, 2011
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    MAX
    PMA / PMN Number
    K100865
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO HAS BEEN REQUESTED AND IF MADE AVAILABLE WILL BE REPORTED IN A SUPPLEMENTAL. METHOD, RESULT, AND CONCLUSION WILL BE MADE AVAILABLE FOLLOWING ENGINEERING EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "THE NAVIGATOR IMPLANT WAS LOADED ONTO THE DRIVER IN THE NORMAL FASHION. THE DRIVER WAS THEN INSPECTED TO ASSURE IT WAS ON CORRECTLY. DR (B)(6) IMPACTED THE DEVICE AND NOTICED THAT THE PORTION OF THE CAGE THAT ATTACHES THE CAGE TO THE INSERTER HAD BROKEN OFF AND REMAINED ON THE INSERTER. THE CAGE WAS IN A GOOD POSITION, HE HAD THE PIECE THAT BROKE OFF¿SO HE USED A SECONDARY IMPACTOR TO FINALLY SEAT THE IMPLANT AND WE MOVED ON. THE CAGE REMAINED IN THE PT IN A GOOD POSITION".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAVIGATOR 10MM X 26MM X 0DEG. SPACER IMPLANT MAX STRYKER SPINE BORDEAUX NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK