BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS

    MDR report key: 8007510 · Received October 25, 2018

    Report

    Report Number
    2031049-2018-00033
    Event Type
    Injury
    Date Received
    October 25, 2018
    Date of Event
    January 24, 2018
    Report Date
    October 25, 2018
    Manufacturer
    TMJ SOLUTIONS, INC.
    Product Code
    LZD
    UDI-DI
    B004TYYNNNNM0
    PMA / PMN Number
    P980052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PATIENT RECEIVED BILATERAL IMPLANTS IN (B)(6) 2016. THE PATIENT BEGAN NOTICING INCREASED SWELLING AND PAIN ON THE LEFT SIDE ABOUT 3-4 WEEKS AFTER SURGERY. AN INCISION AND DRAINAGE WAS PERFORMED IN (B)(6) 2016 AND A SUBCUTANEOUS FLUID COLLECTION WAS NOTED WITH OVERLYING ERYTHEMA (REDNESS) AND EDEMA (SWELLING). THE PATIENT'S CONDITION IMPROVED UNTIL (B)(6) 2017 WHEN SHE NOTICED ACUTE SWELLING AGAIN IN THE LEFT TM JOINT. THE SURGEON REMOVED THE DEVICES IN (B)(6) 2018 AND IS PLANNING ON PLACING REVISION IMPLANTS ONCE THE INFECTION HAS BEEN RESOLVED.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845054 PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS TEMPOROMANDIBULAR JOINT IMPLANT LZD TMJ SOLUTIONS, INC. TYY-NNNNM W36034 B004TYYNNNNM0

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention