BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANTIS CANNULATED MODULAR AWL

    MDR report key: 1841388 · Received September 7, 2010

    Report

    Report Number
    9617544-2010-00309
    Event Type
    Malfunction
    Date Received
    September 7, 2010
    Date of Event
    July 12, 2010
    Report Date
    July 12, 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
    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, "GOING THROUGH MANTIS SET AND NOTICED THAT THE AWL AND THE 6.5 TAP ARE BOTH CHIPPED AT THE TIPS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANTIS CANNULATED MODULAR AWL INSTRUMENT LXH STRYKER SPINE BORDEAUX NA 098281

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK