BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATIENT-FITTED TMJ LEFT FOSSA COMPONENT

    MDR report key: 11971492 · Received June 9, 2021

    Report

    Report Number
    2031049-2021-00037
    Event Type
    Injury
    Date Received
    June 9, 2021
    Date of Event
    June 3, 2021
    Report Date
    June 9, 2021
    Manufacturer
    TMJ SOLUTIONS, LLC.
    Product Code
    LZD
    UDI-DI
    B004TYYNNNNLF0
    PMA / PMN Number
    P980052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SURGEON REMOVED THE LEFT TMJ DEVICES DUE TO INFECTION CAUSED BY P. ACNES (CUTIBACTERIUM ACNES). MULTIPLE MDRS WERE SUBMITTED FOR THIS EVENT. (SEE ASSOCIATED REPORT # 2031049-2021-00038)

    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
    867094 PATIENT-FITTED TMJ LEFT FOSSA COMPONENT LEFT FOSSA COMPONENT LZD TMJ SOLUTIONS, LLC. TYY-NNNLF W54725 B004TYYNNNNLF0

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention