BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IN-SITU PLATE CUTTER, UPPERFACE/MIDFACE

    MDR report key: 2121763 · Received May 20, 2011

    Report

    Report Number
    8010177-2011-00142
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    April 27, 2011
    Report Date
    April 27, 2011
    Manufacturer
    STRYKER OSTEOSYNTHESIS FREIBURG
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROCESS BUT NOT YET COMPLETE.

    Description of Event or Problem · 1

    THE SURGEON WAS CUTTING A PLATE WITH THE IN-SITU CUTTER AND THE CUTTER SNAPPED RIGHT BELOW THE BLADE. THE SURGEON FINISHED CUTTING THE PLATE WITH A DIFFERENT CUTTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IN-SITU PLATE CUTTER, UPPERFACE/MIDFACE INSTRUMENT LXH STRYKER OSTEOSYNTHESIS FREIBURG NA W6

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK