BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATIENT-FITTED TMJ LEFT MANDIBULAR COMPONENT

    MDR report key: 10709044 · Received October 20, 2020

    Report

    Report Number
    2031049-2020-00087
    Event Type
    Injury
    Date Received
    October 20, 2020
    Date of Event
    December 4, 2020
    Report Date
    December 21, 2020
    Manufacturer
    TMJ SOLUTIONS, INC.
    Product Code
    LZD
    UDI-DI
    B004TYYNNNNLM0
    PMA / PMN Number
    P980052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE SURGEON PLANS TO PLACE REVISION LEFT TMJ DEVICES ONCE THE INFECTION IS RESOLVED. MULTIPLE MDRS WERE SUBMITTED (2031049-2020-00086).

    Description of Event or Problem · 0

    THE SURGEON REMOVED THIS PATIENT'S LEFT TMJ DEVICES DUE TO INFECTION.

    Additional Manufacturer Narrative · 1

    THE PATIENT DEVELOPED A DRAINING FISTULA FROM THE SUBMANDIBULAR INCISION. CULTURE SAMPLES WERE TAKEN AND CONFIRMED THE PRESENCE OF (B)(6). THE SURGEON PLANS TO REMOVE THESE DEVICES, TREAT THE INFECTION, AND PLACE REVISION DEVICES LATER (2031049-2020-00086).

    Description of Event or Problem · 1

    THE PATIENT'S LEFT TMJ DEVICES ARE INFECTED AND PENDING REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1167592 PATIENT-FITTED TMJ LEFT MANDIBULAR COMPONENT LEFT MANDIBULAR COMPONENT LZD TMJ SOLUTIONS, INC. TYY-NNNNLM W49729 B004TYYNNNNLM0

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention