BEUDAMED
    FDA Adverse Event Summary report: N

    45MM LFT STANDARD OFF TI MAND

    MDR report key: 1790865 · Received August 10, 2010

    Report

    Report Number
    1032347-2010-00124
    Date Received
    August 10, 2010
    Date of Event
    March 25, 2010
    Report Date
    July 22, 2010
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    LZD
    PMA / PMN Number
    P020016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS FOREIGN; THEREFORE A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. 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

    IT WAS REPORTED THE PATIENT HAD TMJ DEVICES IMPLANTED (DATE UNKNOWN). THE SURGEON FELT A CUSTOM TMJ DEVICE WOULD PROVIDE A BETTER FIT FOR THE PATIENT, SO THE STOCK TMJ WAS EXPLANTED AND THE CUSTOM WAS IMPLANTED ON(B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 45MM LFT STANDARD OFF TI MAND TMJ LZD BIOMET MICROFIXATION 653970

    Patients

    Seq Age Sex Outcome Treatment
    1