BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATIENT-FITTED TMJ LEFT MANDIBULAR COMPONENT

    MDR report key: 10173873 · Received June 19, 2020

    Report

    Report Number
    2031049-2020-00029
    Event Type
    Injury
    Date Received
    June 19, 2020
    Date of Event
    January 15, 2020
    Report Date
    June 19, 2020
    Manufacturer
    TMJ SOLUTIONS, INC.
    Product Code
    LZD
    UDI-DI
    B004TYYNNNNLM0
    PMA / PMN Number
    P980052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT RECEIVED BILATERAL IMPLANTS IN (B)(6) 2011. THE PATIENT DEVELOPED MALOCCLUSION AND PAIN AFTER BEING RECONSTRUCTED WITH ANOTHER MANUFACTURER'S IMPLANTS ON THE CONTRALATERAL SIDE IN 2013 (MFR 2031049-2019-00046). THE SURGEON REMOVED THE CURRENT DEVICES AND PLACED REVISION TMJ IMPLANTS ON BOTH SIDES. MULTIPLE MDR REPORTS REGARDING THE LEFT TMJ FOSSA AND MANDIBULAR REMOVAL WERE SUBMITTED FOR THIS EVENT ( SEE MDR 2031049-2020-00028).

    Description of Event or Problem · 1

    THE PATIENT'S LEFT TMJ DEVICES WERE REMOVED DUE TO MALOCCLUSION AND PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639322 PATIENT-FITTED TMJ LEFT MANDIBULAR COMPONENT LEFT MANDIBULAR COMPONENT LZD TMJ SOLUTIONS, INC. TYY-NNNLM W20074 B004TYYNNNNLM0

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention