BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS

    MDR report key: 8177209 · Received December 18, 2018

    Report

    Report Number
    2031049-2018-00047
    Event Type
    Injury
    Date Received
    December 18, 2018
    Date of Event
    September 11, 2018
    Report Date
    December 18, 2018
    Manufacturer
    TMJ SOLUTIONS, INC.
    Product Code
    LZD
    UDI-DI
    B004TYYNNNNM0
    PMA / PMN Number
    P980052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PATIENT RECEIVED BILATERAL TMJ IMPLANTS IN (B)(6) 2016. THE EXPLANTING SURGEON REPORTED THAT THE IMPLANTING SURGEON HAD PERFORATED THE RIGHT EAC AT THE INITIAL IMPLANT SURGERY, AND IT NEVER HEALED. THE RIGHT TMJ COMPONENTS WERE REMOVED AND AN ANTIBIOTIC SPACER WAS PLACED. THE SURGEON PLANS ON PLACING REVISION COMPONENTS AFTER THE INFECTION HAS BEEN RESOLVED.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1014241 PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS TEMPOROMANDIBULAR JOINT IMPLANT LZD TMJ SOLUTIONS, INC. TYY-NNNNM W35235 B004TYYNNNNM0

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention