BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM

    MDR report key: 4951400 · Received July 29, 2015

    Report

    Report Number
    0001032347-2015-00323
    Event Type
    Injury
    Date Received
    July 29, 2015
    Report Date
    June 30, 2015
    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
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE WARNINGS IN THE PACKAGE INSERT STATE THE PATIENT IS TO BE WARNED THAT THE SYSTEM DOES NOT REPLACE NORMAL HEALTHY BONE IN THEIR TMJ AND THEY MAY CONTINUE TO HAVE CHRONIC PAIN AND LIMITED RANGE OF MOTION. THE TMJ IMPLANTS REMAIN IMPLANTED, THEREFORE, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. 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. REPORT ONE OF FOUR FOR THE SAME EVENT, SEE ALSO 1032347-2015-00324, 1032347-2015-00325 AND 1032347-2015-00326.

    Description of Event or Problem · 1

    THROUGH THE (B)(6) STUDY, THE PATIENT INDICATED FOLLOWING UP WITH HER SURGEON AND REPORTS SHE HAD MANIPULATION UNDER ANESTHESIA AND THE OUTCOME IS SHE IS ABLE TO OPEN HER MOUTH FULLY. NO MEDICAL RECORDS OR ADDITIONAL INFORMATION HAS BEEN PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493729 TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM TMJ RIGHT MANDIBLE LZD BIOMET MICROFIXATION N/A 194590

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention