BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TMJ MED LFT FOSSA COMP

    MDR report key: 2874986 · Received December 17, 2012

    Report

    Report Number
    0001032347-2012-00190
    Event Type
    Injury
    Date Received
    December 17, 2012
    Date of Event
    June 6, 2012
    Report Date
    December 3, 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

    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. 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 REPORTED THROUGH THE (B)(6) STUDY, SHE HAD A LEFT FOSSA EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TMJ MED LFT FOSSA COMP TMJ LZD BIOMET MICROFIXATION N/A 014090

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization