BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANTIS ROD INSERTER INNER SHAFT

    MDR report key: 1931346 · Received November 11, 2010

    Report

    Report Number
    9617544-2010-00457
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    October 13, 2010
    Report Date
    October 13, 2010
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO HAS BEEN REQUESTED AND IF MADE AVAILABLE WILL BE REPORTED IN A SUPPLEMENTAL. METHOD, RESULT, AND CONCLUSION WILL BE MADE AVAILABLE FOLLOWING ENGINEERING EVAL.

    Description of Event or Problem · 1

    NURSE (B)(6) REPORTED VIA OUR SALES REP, (B)(4), THAT SHE OBSERVED A SURGERY. DURING THIS SURGERY SHE OBSERVED THAT THE HOLD MECHANISM FOR THE STICK IS BROKEN WHEN BRINGING IN THE STICK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANTIS ROD INSERTER INNER SHAFT INSTRUMENT LXH STRYKER SPINE BORDEAUX NA 094208

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK