BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HTR-PMI HANSEN LF FRT SP PAR T

    MDR report key: 3102245 · Received May 9, 2013

    Report

    Report Number
    0001032347-2013-00136
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    March 27, 2013
    Report Date
    April 23, 2013
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    GXN
    PMA / PMN Number
    PK953385
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THE WARNINGS IN THE PACKAGE INSERT STATE THIS TYPE OF EVENT CAN OCCUR. THE USER FACILITY IS FOREIGN; THEREFORE, A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. 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

    THE SCREWS AND THE PLATES WERE GETTING LOOSE FROM THE IMPLANT AND THE BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204023 HTR-PMI HANSEN LF FRT SP PAR T HARD TISSUE REPLACEMENT GXN BIOMET MICROFIXATION N/A 413760

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization