BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELASTIC MANDIBULAR ADVANCEMENT APPLIANCE, PRODUCT CODE: LRK

    MDR report key: 7053960 · Received November 22, 2017

    Report

    Report Number
    3011649314-2017-00087
    Event Type
    Malfunction
    Date Received
    November 22, 2017
    Report Date
    November 17, 2017
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Product Code
    LRK
    PMA / PMN Number
    K971794
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT IS CURRENTLY UNDER INVESTIGATION; ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. AS OF THE TIME OF THIS REPORT, THE REPORTED DEVICE HAD NOT YET BEEN RECEIVED, AND WE ARE UNCLEAR IF IT WILL BE PROVIDED. FURTHER FOLLOW-UP IS BEING CONDUCTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NIGHT GUARD BROKE DURING THE MIDDLE OF THE NIGHT. THE PATIENT WAS AWAKENED BY A LOUD POP AND A SHARP POINT IN THE LEFT SIDE OF HER CHEEK. IT WAS DETERMINED THAT THE TOP PIECE OF THE SNORE GUARD HAD SNAPPED INTO 2 PIECES RIGHT BEHIND HER EYE TOOTH (CANINE TOOTH). PATIENT WAS THANKFUL THAT SHE DID NOT SWALLOW THE BROKEN PIECE. ADDITIONAL INFORMATION RECEIVED, THE PATIENT DID NOT SUFFER ANY ADVERSE EVENT NOR SERIOUS INJURY, JUST FELT LIKE SHE MAY OF HAD A SMALL CUT ON THE INSIDE OF THE LEFT CHEEK THAT RESOLVED RIGHT AWAY. THE APPLIANCE WAS CHECKED BACK (B)(6) 2017 WHEN SHE WENT TO THE DOCTOR'S OFFICE FOR HER CLEANING. SHE STATED THAT THE DOCTOR SAID IT WAS IN GOOD CONDITION. THE INCIDENT OCCURRED THE NIGHT OF THE (B)(6) OCTOBER. FURTHER CLARIFICATION WAS RECEIVED THAT THE MANDIBULAR SECTION BROKE IN ½, NO PHOTOS AND UNSURE IF THE DEVICE IS AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833236 ELASTIC MANDIBULAR ADVANCEMENT APPLIANCE, PRODUCT CODE: LRK EMA LRK PRISMATIK DENTALCRAFT, INC. N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR