BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATIENT-FITTED TMJ RIGHT MANDIBULAR COMPONENT

    MDR report key: 10976399 · Received December 9, 2020

    Report

    Report Number
    2031049-2020-00103
    Event Type
    Injury
    Date Received
    December 9, 2020
    Date of Event
    December 9, 2020
    Report Date
    December 9, 2020
    Manufacturer
    TMJ SOLUTIONS, INC.
    Product Code
    LZD
    UDI-DI
    B004TYYNNNNRM0
    PMA / PMN Number
    P980052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SURGEON SUSPECTS THE PATIENT'S RIGHT TMJ DEVICES ARE INFECTED AND IS PLANING ON REMOVING THEM. THE PATIENT IS CURRENTLY ON ANTIBIOTICS. MULTIPLE MDRS WERE SUBMITTED FOR THIS EVENT ((B)(4)).

    Description of Event or Problem · 1

    THE SURGEON REMOVED THE RIGHT TMJ DEVICE DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1445232 PATIENT-FITTED TMJ RIGHT MANDIBULAR COMPONENT RIGHT MANDIBULAR COMPONENT LZD TMJ SOLUTIONS, INC. TYY-NNNNRM W56680 B004TYYNNNNRM0

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention