BEUDAMED
    FDA Adverse Event Injury Summary report: N

    50MM RIGHT STANDARD MANDIBLE

    MDR report key: 3811973 · Received May 15, 2014

    Report

    Report Number
    0001032347-2014-00155
    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

    THE TMJ IMPLANTS WERE EXPLANTED, THE REASON FOR THE REVISION SURGERY IS UNKNOWN. THE REVISION WAS IDENTIFIED WHEN THE TMJ TRACKING CARDS WERE RECEIVED FROM THE HOSPITAL, THE PATIENT DID NOT REPORT THE COMPLAINT. . THIS IS FILE ONE OF TWO FOR THE SAME EVENT, SEE ALSO 1032347-2014-00156-1.

    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.

    Description of Event or Problem · 1

    THE PATIENT REPORTS THE IMPLANTS WERE EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291835 50MM RIGHT STANDARD MANDIBLE TMJ MANDIBLE IMPLANT LZD BIOMET MICROFIXATION N/A 166710A

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R