BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXUS 2

    MDR report key: 549019 · Received October 12, 2004

    Report

    Report Number
    2024312-2004-00001
    Event Type
    Injury
    Date Received
    October 12, 2004
    Date of Event
    June 1, 2004
    Report Date
    June 16, 2004
    Manufacturer
    KERR DENTAL MATERIALS CENTER
    Product Code
    EMA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    IN 2004 A PT CAME INTO THE DOCTOR'S OFFICE FOR DENTAL CARIES TREATMENT. THE PT HAD NO PRE-EXISTING DENTAL PROBLEMS. AFTER USE OF NEXUS 2 THE PT EXPERIENCED PRESSURE AND PAIN. THE DOCTOR PERFORMED A ROOT CANAL AND STATED THAT IF THIS HAD NOT BEEN DONE THE PT WOULD HAVE EXPERIENCED PERMANENT INJURY. THE PT HAS NOT EXPERIENCED ANY ADDITIONAL SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXUS 2 DENTAL CEMENT EMA KERR DENTAL MATERIALS CENTER NA 301415

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention NONE SPECIFIED.