BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SICAT OPTISLEEP

    MDR report key: 6600319 · Received May 31, 2017

    Report

    Report Number
    3006098230-2017-00005
    Event Type
    Malfunction
    Date Received
    May 31, 2017
    Date of Event
    May 2, 2017
    Report Date
    May 30, 2017
    Manufacturer
    SICAT GMBH & CO. KG
    Product Code
    LRK
    UDI-DI
    D776104010
    PMA / PMN Number
    K153291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE ANALYSIS GIVES STRONG INDICATION THAT THE ROOT CAUSE OF THE EVENT IS INSUFFICIENT RETENTION OF THE SICAT OPTISLEEP DEVICE. DURING SLEEP THE MANDIBULAR PART OF THE DEVICE DISLODGED FROM THE CORRECT POSITION ON THE MANDIBLE. SIMULATIONS SHOW THAT FORCES FROM BITING ON THE DEVICE IN DISLODGED POSITION ACCURATELY REPRODUCE THE PATTERN OF THE FRACTURE OF THE DEVICE. THE DENTIST RECOMMENDED TO REPORT THE EVENT. HE THINKS, THAT IF A SIMILAR EVENT WERE TO RECUR, SMALL PIECES OF A FRACTURED DEVICE MIGHT BE ASPIRATED, POSSIBLY RESULTING IN A SERIOUS INJURY.

    Description of Event or Problem · 1

    THE REPORTING DENTIST REPORTS THAT A SICAT OPTISLEEP ANTI-SNORING DEVICE BROKE WHILE THE PATIENT WAS SLEEPING. AT THE DISTOLINGUAL EDGE OF THE OPTISLEEP DEVICE A PIECE OF ABOUT 2 X 5 MM BROKE OFF. THE PATIENT DID NOT SWALLOW OR ASPIRATE ANY PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381239 SICAT OPTISLEEP INTRAORAL DEVICE FOR SNORING AND OBSTRUCTIVE SLEEP APNEA LRK SICAT GMBH & CO. KG D776104010

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR