BEUDAMED
    FDA Adverse Event Other Summary report: N

    2" FLEX QC SHAFT EXTENSION

    MDR report key: 1200263 · Received October 2, 2008

    Report

    Report Number
    1032347-2008-00061
    Event Type
    Other
    Date Received
    October 2, 2008
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    MQN
    PMA / PMN Number
    K992952
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT IS TO BE RETURNED FOR EVALUATION, BUT HAS NOT YET BEEN RECEIVED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION 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. THE USER FACILITY IS FOREIGN; THEREFORE, A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE.

    Description of Event or Problem · 1

    DISTRACTION DEVICE HAS BEEN IMPLANTED ABOUT 3 WEEKS, AND HAD DISTRACTED ABOUT 10MM, WHEN IT WAS NOTICED, THE FLEX SHAFT EXTENSION WAS BROKEN. A REVISION SURGERY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2" FLEX QC SHAFT EXTENSION DISTRACTION DEVICE MQN BIOMET MICROFIXATION 370750

    Patients

    Seq Age Sex Outcome Treatment
    1 16 MO Hospitalization