BEUDAMED
    FDA Adverse Event Other Summary report: N

    2.0MM 2X34 HOLE STRIP PLATE

    MDR report key: 1060870 · Received May 30, 2008

    Report

    Report Number
    1032347-2008-00024
    Event Type
    Other
    Date Received
    May 30, 2008
    Manufacturer
    BIOMET MICROFIXATION, INC.
    Product Code
    JEY
    PMA / PMN Number
    K953385
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFO IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADD'L INFO IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ABOUT A WEEK POST OP THE PT SAW THE DOCTOR AND IT WAS DISCOVERED THE JAW WAS MISALIGNED. THE DOCTOR FOUND THE SCREWS AND PLATES WERE NOT FIXATED IN THE BONE. A REVISION SURGERY WAS PERFORATED TO CORRECT. (DATES IMPLANTED & REVISION DATE IS NOT KNOWN.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2.0MM 2X34 HOLE STRIP PLATE BONE PLATE JEY BIOMET MICROFIXATION, INC. 469930

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization UNK WHICH SCREW OR HOW MANY WERE USED.| SCREWS WERE USED TO FIXATE THE PLATE