BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HTR-PMI ALBREC RT FRT SP PAR T

    MDR report key: 2471995 · Received February 29, 2012

    Report

    Report Number
    0001032347-2012-00015
    Event Type
    Injury
    Date Received
    February 29, 2012
    Report Date
    February 21, 2012
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    KKY
    PMA / PMN Number
    PK924935
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 PATIENT HAD THE HTR REMOVED DUE TO AN INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HTR-PMI ALBREC RT FRT SP PAR T HARD TISSUE REPLACEMENT KKY BIOMET MICROFIXATION N/A 281260

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization