BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXFIRE MARXMEN STRAIGHT

    MDR report key: 2810055 · Received October 31, 2012

    Report

    Report Number
    0001825034-2012-02294
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 3, 2012
    Manufacturer
    BIOMET SPORTS MEDICINE
    Product Code
    MBI
    PMA / PMN Number
    PK1111564
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 0001825034-2012-02293 / 02294).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A MENISCAL REPAIR, WHEN THE SURGEON WENT TO TIGHTEN IT, IT PULLED OUT. TWO MARXMEN WERE UNSUCCESSFUL IN REPAIRING THE MENISCUS AND HALF OF ONE BECAME STUCK IN THE PATIENT. THE SURGEON WAS UNABLE TO REMOVE THE STUCK IMPLANT. THE SURGERY WAS COMPLETED USING COMPETITOR'S DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXFIRE MARXMEN STRAIGHT FASTNER, FIXATION MBI BIOMET SPORTS MEDICINE N/A 417150

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R