BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATIENT-FITTED TMJ RIGHT FOSSA COMPONENT

    MDR report key: 10976402 · Received December 9, 2020

    Report

    Report Number
    2031049-2020-00102
    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
    B004TYYNNNNRF0
    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 (REFERENCE: 2031049-2020103).

    Description of Event or Problem · 1

    THE RIGHT TMJ DEVICES WERE REMOVED DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1445231 PATIENT-FITTED TMJ RIGHT FOSSA COMPONENT RIGHT FOSSA COMPONENT LZD TMJ SOLUTIONS, INC. TYY-NNNNRF W56679 B004TYYNNNNRF0

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention