BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TMJ SMALL RIGHT FOSSA COMPONENT

    MDR report key: 3812027 · Received May 15, 2014

    Report

    Report Number
    0001032347-2014-00156
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    November 9, 2011
    Report Date
    November 11, 2011
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    LZD
    PMA / PMN Number
    PP020016
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS FILE TWO OF TWO FOR THE SAME EVENT, SEE ALSO 1032347-2014-00155-1.

    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. WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION 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

    DURING A TMJ RECONCILIATION, IT WAS IDENTIFIED THAT TMJ TRACKING CARDS WERE RECEIVED AT BIOMET INDICATING THE IMPLANTS WERE EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289928 TMJ SMALL RIGHT FOSSA COMPONENT TMJ FOSSA LZD BIOMET MICROFIXATION N/A 291800B

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R