BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZQUIET

    MDR report key: 2259090 · Received September 13, 2011

    Report

    Report Number
    3008797926-2011-00001
    Event Type
    Injury
    Date Received
    September 13, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 2, 2011
    Manufacturer
    SLEEPING WELL LLC
    Product Code
    LRK
    PMA / PMN Number
    K093407
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURN OF THE DEVICE HAS BEEN REQUESTED AND A FULL INVESTIGATION WILL BE CONDUCTED ON RECEIPT OF THE DEVICE. HOWEVER, IT IS UNLIKELY THAT WEARING THE DEVICE COULD RESULT IN SUFFICIENT FORCE ON THE TEETH AS TO CAUSE CRACKING OF POSTS ON A PORCELAIN IMPLANTS. NO OTHER REPORTS OF DAMAGE TO IMPLANTS HAVE BEEN RECEIVED. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER A FULL INVESTIGATION HAS BEEN CONDUCTED.

    Description of Event or Problem · 1

    CLIENT REPORTED THAT, SIX MONTHS AFTER STARTING TO USE A ZQUIET, HIS DENTIST EVALUATED THE PORCELAIN IMPLANTS ON HIS FRONT TWO TEETH AND DETERMINED THAT THE POSTS WERE CRACKED. THE CLIENT BELIEVES IT WAS DUE TO THE PRESSURE OF THE ZQUIET ON HIS FRONT TEETH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZQUIET ZQUIET LRK SLEEPING WELL LLC REV. 17D

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention