BEUDAMED
    FDA Adverse Event Injury Summary report: N

    45MM RT STANDARD MAND

    MDR report key: 3891316 · Received June 24, 2014

    Report

    Report Number
    0001032347-2014-00190
    Event Type
    Injury
    Date Received
    June 24, 2014
    Report Date
    May 30, 2014
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    LZD
    PMA / PMN Number
    PP020016
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    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. WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. THE CUSTOMER INDICATES THE REVISION WAS NOT AS A RESULT OF ANY FAILURE OF THE IMPLANT MANUFACTURED BY BIOMET MICROFIXATION. 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

    A TMJ REVISION SURGERY OCCURRED TO REPLACE THE IMPLANT WITH ANOTHER MANUFACTURER'S IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368190 45MM RT STANDARD MAND TMJ LZD BIOMET MICROFIXATION N/A 433470B

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization