BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM

    MDR report key: 5870080 · Received August 11, 2016

    Report

    Report Number
    0001032347-2016-00396
    Event Type
    Injury
    Date Received
    August 11, 2016
    Date of Event
    July 1, 2016
    Report Date
    July 13, 2016
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    LZD
    PMA / PMN Number
    PP020016
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR AN EVALUATION, HOWEVER AN EVALUATION OF THE COMPLAINT WAS CONDUCTED. BASED ON THE EVALUATION, FIELD WAS UPDATED TO REFLECT THE OPERATIONAL PROBLEM OF: "PARTS DON'T MOVE FREELY." THIS IS REPORT TWO OF FIVE FOR THE SAME EVENT. REPORTS ONE, AND THREE THROUGH FIVE ARE REPORTED ON 1032347-2016-00395-1 AND 1032347-2016-00397-1 THROUGH 1032347-2016-00399-1.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THE PATIENT IS IN JAIL AND THE SURGEON BELIEVES THE EVENT WAS DUE TO THE PATIENT NOT HAVING ACCESS TO ORAL CARE. REVIEW OF DEVICE HISTORY RECORDS SHOW THE LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THE WARNINGS IN THE PACKAGE INSERT STATE THIS TYPE OF EVENT CAN OCCUR. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT A FOLLOW-UP REPORT WILL BE SENT. REPORT TWO OF FIVE FOR THE SAME EVENT, REFERENCE 1032347-2016-00395 THROUGH 1032347-2016-00399.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ALL PREVIOUSLY IMPLANTED PRODUCTS WERE RE-IMPLANTED INTO THE PATIENT ONCE THE PATIENT'S CONDITION WAS RESOLVED.

    Description of Event or Problem · 1

    A REVISION SURGERY WAS REPORTED DUE TO ANKYLOSIS OVER THE JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521165 TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM 50MM RIGHT STANDARD MANDIBLE LZD BIOMET MICROFIXATION N/A 190880

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R