BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATIENT-FITTED TMJ RIGHT FOSSA COMPONENT

    MDR report key: 12368725 · Received August 25, 2021

    Report

    Report Number
    2031049-2021-00055
    Event Type
    Injury
    Date Received
    August 25, 2021
    Date of Event
    August 17, 2021
    Report Date
    August 25, 2021
    Manufacturer
    TMJ SOLUTIONS, LLC
    Product Code
    LZD
    UDI-DI
    B004TYYNNNNRF0
    PMA / PMN Number
    P980052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PATIENT PREVIOUSLY HAD A DEBRIDEMENT SURGERY A FEW MONTHS AGO ON THE RIGHT SIDE (REFERENCE MFG REPORT#2031049-2021-00025). THE SURGEON HAS BEEN SINCE REMOVED THE DEVICES DUE TO A SUSPECTED INFECTION (MULTIPLE REPORTS WERE FILED FOR THIS EVENT MFG REPORT #2031049-2021-00056).

    Description of Event or Problem · 1

    THE PATIENT'S RIGHT TMJ DEVICES WERE REMOVED DUE TO A SUSPECTED INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1265270 PATIENT-FITTED TMJ RIGHT FOSSA COMPONENT RIGHT FOSSA COMPONENT LZD TMJ SOLUTIONS, LLC TYY-NNNNRF W53161 B004TYYNNNNRF0

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention