BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROCERA BRIDGE ZIRCONIA 4 UNIT MEDIUM

    MDR report key: 6725352 · Received July 19, 2017

    Report

    Report Number
    3003719670-2017-00002
    Event Type
    Malfunction
    Date Received
    July 19, 2017
    Date of Event
    September 26, 2016
    Report Date
    September 29, 2016
    Manufacturer
    NOBEL BIOCARE
    Product Code
    NSN
    PMA / PMN Number
    K053125
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCING QUALITY NOTIFICATION # (B)(4). CONTINUED MONITORING OF ALL COMPLAINTS OF THIS TYPE WILL CONTINUE TO BE CONDUCTED. NO FURTHER CORRECTIVE OR PREVENTIVE ACTIONS ARE PLANNED.

    Description of Event or Problem · 1

    PIGMENTATION, BLUE/GRAY DISCOLORATION OF THE MUCOSA. PIGMENTATION BOTH AGAINST THE LIP AND PALATE. ACCORDING TO THE CLINICIAN, THE DISCOLORATION IS NOT AMALGAM TATTOOS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505493 PROCERA BRIDGE ZIRCONIA 4 UNIT MEDIUM PROCERA BRIDGE NSN NOBEL BIOCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other