BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNITEK(TM) MULTI-CURE GLASS IONOMER ORTHODONTIC BAND CEMENT

    MDR report key: 5185770 · Received October 28, 2015

    Report

    Report Number
    2020467-2015-00001
    Event Type
    Injury
    Date Received
    October 28, 2015
    Date of Event
    September 21, 2015
    Report Date
    September 30, 2015
    Manufacturer
    3M UNITEK CORPORATION
    Product Code
    DYH
    PMA / PMN Number
    K950514
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ADOLESCENT FEMALE WHO STARTED ORTHODONTIC TREATMENT IN 2014 WENT TO THE ORTHODONTIST COMPLAINING OF A TOOTHACHE ON TOOTH 26 (UPPER LEFT 1ST MOLAR). IN ORDER TO X-RAY THE TOOTH, THE MOLAR BAND WAS REMOVED. WHEN THE BAND WAS REMOVED, DENTAL CARIES (TOOTH DECAY) WAS DISCOVERED THAT AFFECTED THE TOOTH'S PULP CHAMBER, ON THE GINGIVAL/LINGUAL SIDE OF THE MOLAR. THIS WAS VERY LIKELY THE CAUSE OF THE PATIENT'S TOOTHACHE. THE PATIENT'S ORAL HYGIENE WAS DESCRIBED AS "MEDIUM" BY THE ORTHODONTIST. DENTAL CARIES IS THE RESULT OF BACTERIA-INDUCED BREAKDOWN OF THE HARD TISSUES OF THE TOOTH BY PROGRESSIVE LOCAL DEMINERALIZATION. THE CAUSE OF THE CARIES WAS LIKELY A LACK OF THOROUGH ORAL HYGIENE, AS PLAQUE CAN BUILD UP AROUND ORTHODONTIC APPLIANCES. BECAUSE THE HARD TISSUES OF THE TOOTH WERE BROKEN DOWN BY THE CARIES, THE REMOVAL OF THE BAND CAUSED THE CAVITY TO APPEAR IN THE TOOTH. THERE IS NO REASON TO BELIEVE THAT THERE WAS A MALFUNCTION OF THE GLASS IONOMER BAND CEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712965 UNITEK(TM) MULTI-CURE GLASS IONOMER ORTHODONTIC BAND CEMENT ORTHODONTIC ADHESIVE DYH 3M UNITEK CORPORATION GF9VB

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention