BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HTR-PMI WOLFE LF FRT PAR TEMP

    MDR report key: 2480257 · Received March 6, 2012

    Report

    Report Number
    0001032347-2012-00022
    Event Type
    Injury
    Date Received
    March 6, 2012
    Report Date
    February 29, 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
    WA, US
    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 IS HAVING A REVISION SURGERY DUE TO AN INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HTR-PMI WOLFE LF FRT PAR TEMP HARD TISSUE REPLACEMENT KKY BIOMET MICROFIXATION N/A 295220

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization