BEUDAMED
    FDA Adverse Event Injury Summary report: N

    45MM LFT NARROW MAND

    MDR report key: 3070047 · Received April 22, 2013

    Report

    Report Number
    0001032347-2013-00106
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    August 30, 2012
    Report Date
    August 30, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE WARNINGS IN THE PACKAGE INSERT STATE THIS TYPE OF EVENT CAN OCCUR. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. 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

    THROUGH THE (B)(6) STUDY A REVISION SURGERY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172592 45MM LFT NARROW MAND TMJ FOSSA LZD BIOMET MICROFIXATION N/A 747530

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization