BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T.RODRIGUEZ RUIZ RIGHT PM-TMJ

    MDR report key: 1954411 · Received January 10, 2011

    Report

    Report Number
    1032347-2011-00005
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    August 31, 2010
    Report Date
    August 31, 2010
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    KKY
    PMA / PMN Number
    K924935
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS FOREIGN; THEREFORE A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. THE WARNINGS IN THE PACKAGE INSERT STATE THIS TYPE OF EVENT CAN OCCUR. 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 HARD TISSUE REPLACEMENT (HTR) IMPLANTED (B)(6) 2010. THREE MONTHS AFTER THE HTR WAS IMPLANTED, HE BEGAN TO DEVELOP INFLAMMATORY SYMPTOMS AND DRAINAGE WAS PERFORMED IN A LOCAL HOSPITAL. ON (B)(6) 2010, THE PATIENT WAS ADMITTED AGAIN AND DIAGNOSED WITH AN INFECTION SO THE HTR WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 T.RODRIGUEZ RUIZ RIGHT PM-TMJ HARD TISSUE REPLACEMENT KKY BIOMET MICROFIXATION 22865A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization