BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IN-SITU PLATE CUTTER, UPPERFACE/MIDFACE

    MDR report key: 2043363 · Received February 25, 2011

    Report

    Report Number
    8010177-2011-00054
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    February 3, 2011
    Report Date
    February 3, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROCESS BUT NOT YET COMPLETE.

    Description of Event or Problem · 1

    WHILE THE SURGEON WAS CUTTING A MANDIBLE PLATE, A PIECE OF ONE OF THE BLADES CAME APART FROM THE INSTRUMENT. THE PIECE WAS RETRIEVED AND DISCARDED, AND NO FURTHER ADVERSE CIRCUMSTANCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IN-SITU PLATE CUTTER, UPPERFACE/MIDFACE INSTRUMENT LXH STRYKER OSTEOSYNTHESIS FREIBURG NA Y6

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK