BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATIENT-FITTED TMJ LEFT FOSSA COMPONENT

    MDR report key: 10944125 · Received December 4, 2020

    Report

    Report Number
    2031049-2020-00101
    Event Type
    Injury
    Date Received
    December 4, 2020
    Report Date
    December 3, 2020
    Manufacturer
    TMJ SOLUTIONS, INC.
    Product Code
    LZD
    PMA / PMN Number
    P980052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SURGEON REMOVED THE LEFT'S FOSSA COMPONENT. SEVERAL ATTEMPTS HAVE BEEN MADE TO COLLECT MORE INFORMATION. SUPPLEMEMT REPORT WILL BE SUBMITTED WHEN INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    THE SURGEON REMOVED THE LEFT FOSSA COMPONENT .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1414046 PATIENT-FITTED TMJ LEFT FOSSA COMPONENT LEFT FOSSA COMPONENT LZD TMJ SOLUTIONS, INC. TYY-NNNLF W14477

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention