BEUDAMED
    FDA Adverse Event Injury Summary report: N

    45MM LFT NARROW MAND

    MDR report key: 1962540 · Received January 18, 2011

    Report

    Report Number
    1032347-2011-00006
    Event Type
    Injury
    Date Received
    January 18, 2011
    Date of Event
    November 30, 2010
    Report Date
    January 6, 2011
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    LZD
    PMA / PMN Number
    P020016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE SURGEON, THERE WAS NO INDICATION OF THE DEVICE NOT FUNCTIONING AS INTENDED. THE WARNINGS IN THE PACKAGE INSERT STATE THIS TYPE OF EVENT CAN OCCUR. 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. THERE WERE 2 IMPLANTS EXPLANTED FROM THIS PATIENT. SEE MDR 1032347-2011-00007 ALSO.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A BILATERAL TMJ DEVICES IMPLANTED (B)(6) 2010. THE PATIENT WAS COMPLAINING OF PAIN AND FACIAL SWELLING, SO THE SURGEON EXPLANTED THE LEFT SIDE IMPLANTS ON (B)(6) 2010. HE REPLACED THEM WITH A CUSTOM TMJ DEVICE. THE RIGHT SIDE IMPLANTS REMAIN IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 45MM LFT NARROW MAND TMJ LZD BIOMET MICROFIXATION 704240

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization