BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TMJ SM LFT FOSSA COMP

    MDR report key: 2833469 · Received November 15, 2012

    Report

    Report Number
    0001032347-2012-00162
    Event Type
    Injury
    Date Received
    November 15, 2012
    Report Date
    October 23, 2012
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    LZD
    PMA / PMN Number
    PP020016
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE WARNINGS IN THE PACKAGE INSERT STATE THIS TYPE OF EVENT CAN OCCUR. WITHOUT A PRODUCT RETURN, NO PRODUCT EVAUATION IS ABLE TO BE CONDUCTED. 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 REPORTS THROUGH THE (B)(6) STUDY THAT SHE HAD A REVISION SURGERY AFTER EXPERIENCING DISLOCATION OF PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TMJ SM LFT FOSSA COMP TMJ LZD BIOMET MICROFIXATION N/A 297220

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Hospitalization