BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM

    MDR report key: 4038155 · Received August 26, 2014

    Report

    Report Number
    0001032347-2014-00259
    Event Type
    Injury
    Date Received
    August 26, 2014
    Date of Event
    July 14, 2014
    Report Date
    July 30, 2014
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    LZD
    PMA / PMN Number
    PP020016
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND ANALYZED AS PART OF THE (B)(6) STUDY. THIS SUPPLEMENTAL REPORT IS LATE INFORMATION RECEIVED FROM THE (B)(6) STUDY (B)(6), WHICH WAS REPORTED AS EXPECTED TO THE (B)(6) STUDIES PROGRAM, BUT INADVERTENTLY NOT RECOGNIZED AS 803 REPORTABLE UNTIL AFTER THE CLOSE OF THE STUDY. ACCORDING TO THE STUDY: NO FAILURE MODE WAS IDENTIFIED. ADDITIONALLY, THE PATIENT EXPERIENCED CHRONIC PAIN AND SWELLING. CULTURE OF THE PERI-IMPLANT TISSUE FOUND EVIDENCE OF INFECTION THAT MAY HAVE CONTRIBUTED TO THE DEVICE FAILURE. THIS IS SUPPLEMENTAL REPORT 2 OF 2 FOR THE SAME EVENT. SUPPLEMENTAL REPORT 1 OF 2 IS REPORTED ON MFR #0001032347-2014-00257-1.

    Additional Manufacturer Narrative · 1

    THE INSTRUCTIONS FOR USE (IFU) AND THE PATIENT BROCHURE BOTH INDICATE INFECTION AND PAIN AS POSSIBLE ADVERSE EVENTS. THE USER FACILITY REPORTS THAT THE REVISION WAS SUCCESSFUL AND THE PATIENT HAS BEEN DISCHARGED FROM THE HOSPITAL IN STABLE CONDITION. THE OPERATIVE REPORT STATES THERE IS NO EVIDENCE OF HARDWARE FAILURE. VISUAL EVALUATION OF THE RETURNED IMPLANTS CONFIRMED NO EVIDENCE OF EXCESSIVE WEAR. 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. FILE TWO OF FIVE FOR THE SAME EVENT.

    Description of Event or Problem · 1

    THE SURGEON INFORMED THE CLINICAL RESEARCH STAFF OF A REVISION SURGERY DUE TO AN INFECTION AND CHRONIC PAIN. THE OPERATIVE REPORT STATES "FINDINGS: NO EVIDENCE OF HARDWARE FAILURE AND NO EVIDENCE OF ANY CHRONIC GRANULATION TISSUE. NO EVIDENCE OF INFECTION. THE SOFT TISSUE AROUND BOTH DEVICES WAS MATURE. SOFT TISSUE BIOPSIES AS WELL AS CULTURES WERE OBTAINED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    516447 TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM 50MM RT NARRROW MAND LZD BIOMET MICROFIXATION N/A 182640

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| R