BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS

    MDR report key: 8180288 · Received December 19, 2018

    Report

    Report Number
    2031049-2018-00048
    Event Type
    Injury
    Date Received
    December 19, 2018
    Date of Event
    July 27, 2017
    Report Date
    December 19, 2018
    Manufacturer
    TMJ SOLUTIONS, INC.
    Product Code
    LZD
    PMA / PMN Number
    P980052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PATIENT RECEIVED BILATERAL TMJ IMPLANTS IN (B)(6) 2015. THE PATIENT STARTED TO EXPERIENCE PAIN AND SWELLING DUE TO A DISCHARGING SINUS ANTERIOR WALL OF THE LEFT EAC. THE SURGEON REMOVED THE LEFT TMJ IMPLANTS IN (B)(6) 2017 DUE TO AN INFECTION THAT WAS SUSPECTED TO BE CAUSED BY STAPH, AND PLACED AN ANTIBIOTIC SPACER. AFTER THE INFECTION RESOLVED, REVISION COMPONENTS WERE IMPLANTED IN (B)(6) 2018.

    Description of Event or Problem · 1

    THE PATIENT'S LEFT TMJ DEVICES WERE REMOVED DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1020130 PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS TEMPOROMANDIBULAR JOINT IMPLANT LZD TMJ SOLUTIONS, INC. TYY-NNNM W33123

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention