BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM

    MDR report key: 4202211 · Received October 27, 2014

    Report

    Report Number
    0001032347-2014-00373
    Event Type
    Injury
    Date Received
    October 27, 2014
    Report Date
    October 22, 2014
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    LZD
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT EVALUATION WAS COMPLETED ON THE RETURNED DEVICE. PER THE PRODUCT EVALUATION: "THE RETURNED TMJ WAS EVALUATED FOR THE COMPLAINT THAT THE FOSSA IMPLANT WAS ROCKING AND UNSTABLE WHEN PLACED IN THE PATIENT¿S MOUTH. UPON EVALUATION THE FOSSA IMPLANT FIT THE MODEL WITH NO ISSUES AND NO DAMAGE WAS SEEN ON ANY OF THE COMPONENTS. A RECENT CT SCAN SHOWED THE PATIENT¿S ANATOMY CHANGED FROM THE CT SCAN TAKEN FOR THE DESIGN OF THE FOSSA. THE SURGEON WAS NOTIFIED THAT THE SCAN WAS OVER SIX MONTHS AND APPROVED MOVING FORWARD WITHOUT A NEW SCAN. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. THE MOST LIKELY UNDERLYING CAUSE OF THE COMPLAINT ISSUE IS AN EXTENDED TIME PERIOD BETWEEN THE CT SCAN FOR THE DESIGN AND THE SURGERY."

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED THAT THE CUSTOM FOSSA IMPLANT WAS ROCKING AND UNSTABLE WHEN PLACED IN PATIENT'S MOUTH, THEREFORE, THE SURGERY COULD NOT BE COMPLETED. SPACERS WERE PLACED UNTIL A NEW FOSSA CAN BE MADE. A 45-60 MINUTE SURGICAL DELAY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683972 TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM RIGHT PM-TMJ & MODEL LZD BIOMET MICROFIXATION N/A 564260A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization