BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXUS LUTING SYSTEM

    MDR report key: 190828 · Received October 5, 1998

    Report

    Report Number
    2024312-1998-00002
    Event Type
    Injury
    Date Received
    October 5, 1998
    Date of Event
    May 22, 1998
    Report Date
    September 3, 1998
    Manufacturer
    KERR DENTAL MATERIALS CENTER
    Product Code
    EMA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THIS REPORT WAS REC'D VIA THE DENTIST WHO REPORTED THAT THE PT EXPERIENCED EXCRUCIATING PAIN AFTER BEING EXPOSED TO NEXUS LUTING CEMENT. EMERGENCY ENDODONTIC TREATMENT, INCLUDING REPLACEMENT OF A CROWN WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXUS LUTING SYSTEM DENTAL CEMENT EMA KERR DENTAL MATERIALS CENTER NA 704611

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention