BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM

    MDR report key: 5848813 · Received August 4, 2016

    Report

    Report Number
    0001032347-2016-00378
    Event Type
    Injury
    Date Received
    August 4, 2016
    Report Date
    July 7, 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
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE WARNINGS IN THE PACKAGE INSERT STATES "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." WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. THE LOT NUMBER IS UNKNOWN; THEREFORE THE DEVICE HISTORY RECORDS ARE UNABLE TO BE REVIEWED. 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 THREE OF FOUR FOR THE SAME EVENT, REFERENCE 1032347-2016-00377 THROUGH 1032347-2016-00379.

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS CONTACTED FOR FOLLOW UP AND SHE STATED SHE HAS NOT SEEN HER SURGEON AT THIS TIME; NO PROCEDURES OR TREATMENT HAVE BEEN PERFORMED. CORRECTION TO PREVIOUSLY SUBMITTED NARRATIVE WHICH STATED "THE LOT NUMBER IS UNKNOWN; THEREFORE THE DEVICE HISTORY RECORDS ARE UNABLE TO BE REVIEWED." THE LOT NUMBER IS KNOWN AND NO NON-CONFORMANCE WAS FOUND FOR THIS LOT. SUPPLEMENTAL REPORT THREE OF FOUR FOR THE SAME EVENT, REFERENCE 1032347-2016-00376-1 THROUGH 1032347-2016-00379-1.

    Description of Event or Problem · 1

    THE PATIENT REPORTED PAIN AND HER IMPLANT STARTED SQUEAKING AND SHE CAN¿T OPEN HER MOUTH VERY WIDE AFTER SHE HAD A DENTAL PROCEDURE. SHE STATED SHE WILL UNDERGO AN EXPLORATORY PROCEDURE TO DETERMINE THE CAUSE ON (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499046 TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM 50MM LEFT NARROW MANDIBLE LZD BIOMET MICROFIXATION N/A 023200

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R