BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANTIS ROD INSERTER INNER SHAFT

    MDR report key: 1993621 · Received January 6, 2011

    Report

    Report Number
    9617544-2010-00515
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    November 30, 2010
    Report Date
    December 1, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DR (B)(6), HEAD OF THE THEATER, REPORTED VIA OUR SALES REP, (B)(6), THAT DURING A SURGERY, THE CONNECTION OF THE ROD WITH LOT# 09C183 IS BROKEN. AT THE SUBSTITUTE INSTRUMENT (LOT# 09A430), A BREAK OF THE SIDE ROD WAS OBSERVED. THE SURGERY HAS BEEN DELAYED BY THIRTY MINUTES. THE DESIRED OPERATION RESULT COULD BE ACHIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANTIS ROD INSERTER INNER SHAFT INSTRUMENT LXH STRYKER SPINE BORDEAUX NA 09C183

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK