BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANTIS CANNULATED MODULAR AWL

    MDR report key: 1582469 · Received January 11, 2010

    Report

    Report Number
    9617544-2010-00005
    Event Type
    Malfunction
    Date Received
    January 11, 2010
    Date of Event
    December 28, 2009
    Report Date
    December 28, 2009
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    HWJ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 CODES WILL BE MADE AVAILABLE FOLLOWING ENGINEERING EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "I CAME ACROSS THIS BEING BROKEN WHEN I WAS INVENTORYING THE SET."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANTIS CANNULATED MODULAR AWL INSTRUMENT HWJ STRYKER SPINE BORDEAUX NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK