BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HTR PMI LUTOMSKI

    MDR report key: 2055753 · Received April 14, 2011

    Report

    Report Number
    1032347-2011-00051
    Event Type
    Injury
    Date Received
    April 14, 2011
    Report Date
    March 15, 2011
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    GXN
    PMA / PMN Number
    K924935
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. EXACT DATE OF EXPLANT IS NOT PROVIDED; ABOUT 1-1.5 WEEKS POST OP. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD HTR IMPLANTED (B)(6) 2011, ABOUT 5-7 DAYS POST OP, THE PATIENT DEVELOPED AN INFECTION. THE SURGEON DECIDED TO EXPLANT THE HTR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HTR PMI LUTOMSKI HARD TISSUE REPLACEMENT GXN BIOMET MICROFIXATION 308750

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization