BEUDAMED
    FDA Adverse Event Other Summary report: N

    NARVAL CC ORTHESE MRD

    MDR report key: 2858160 · Received October 31, 2012

    Report

    Report Number
    3004604967-2012-00042
    Event Type
    Other
    Date Received
    October 31, 2012
    Date of Event
    September 1, 2012
    Report Date
    October 31, 2012
    Manufacturer
    RESMED SAS - DENTAL SLEEP BUSINESS
    Product Code
    LQZ
    PMA / PMN Number
    K113201
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO RESMED FOR INVESTIGATION. HOWEVER, THE DEVICE WAS MANUFACTURED BY RESMED IN ACCORDANCE TO THE DENTIST'S PRESCRIPTION. BASED ON THE INFO PROVIDED BY THE DENTIST, THIS PT HAD PREVIOUS ORTHODONTIC WORK AND WAS USING ANOTHER MRD DEVICE FOR 8 YRS PRIOR TO USING THE NARVAL DEVICE. IT IS UNK IF THE PREVIOUS DEVICE LOADED OR APPLIED PRESSURE TO THE INCISORS. THE DESIGN OF THE NARVAL DEVICE DOES NOT TRADITIONALLY LOAD THE INCISORS. IT IS DESIGNED TO REST ON THE MOST SOLID TEETH (THE UPPER MAXILLA AT THE CANINES AND ON THE MANDIBULAR MOLARS). THE DESIGN ALSO ADVANCES THE MANDIBLE AS PARALLEL AS POSSIBLE TO THE PT'S OCCLUSAL PLANE, THEREBY REDUCING LOCAL FORCES AND PRESSURE ON INDIVIDUAL TEETH OR DENTAL SEGMENTS, THEREBY LIMITING THE RISK OF MOVEMENT. FURTHERMORE, THE PRESCRIBING DENTIST IS ABLE TO EASILY CONTROL AND MODIFY THE DEGREE OF MANDIBULAR ADVANCEMENT WHICH CAN ALSO REDUCE THE FORCES DIRECTED TO THE TEETH. NARVAL INSTRUCTIONS INCLUDE A WARNING STATEMENT THAT "USE OF THE DEVICE MAY CAUSE: TOOTH MOVEMENT OR CHANGES IN DENTAL OCCLUSION." THE PT IS CURRENTLY ON THERAPY AND USING HIS FORMER DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO RESMED THAT A PT WEARING A NARVAL MANDIBULAR REPOSITIONING DEVICE (MRD) HAD SIGNIFICANT TEETH MOVEMENT AFTER THREE WEEKS OF USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NARVAL CC ORTHESE MRD LQZ RESMED SAS - DENTAL SLEEP BUSINESS 200002

    Patients

    Seq Age Sex Outcome Treatment
    1 Other