BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATIENT-FITTED TMJ LEFT MANDIBULAR COMPONENT

    MDR report key: 10194980 · Received June 25, 2020

    Report

    Report Number
    2031049-2020-00035
    Event Type
    Injury
    Date Received
    June 25, 2020
    Date of Event
    March 21, 2017
    Report Date
    June 25, 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

    MULTIPLE MDR'S WERE FILED FOR THIS EVENT (SEE ASSOCIATED REPORT 2031049-2020-00034).

    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
    661591 PATIENT-FITTED TMJ LEFT MANDIBULAR COMPONENT LEFT MANDIBULAR COMPONENT LZD TMJ SOLUTIONS, INC. TYY-NNNNLM W39131 B004TYYNNNNLM0

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention