BEUDAMED
    FDA Adverse Event Other Summary report: N

    AMI

    MDR report key: 3229833 · Received July 10, 2013

    Report

    Report Number
    3002906930-2013-00001
    Event Type
    Other
    Date Received
    July 10, 2013
    Date of Event
    March 3, 2013
    Report Date
    July 10, 2013
    Manufacturer
    AIRWAY MANAGEMENT INC.
    Product Code
    LRK
    PMA / PMN Number
    K062951
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS CUSTOM FABRICATED ON THE SIGNED PRESCRIPTION OF A LICENSED DENTIST FOR THE CONTINUE USE BY A SINGLE PT. THE DEVICE IS INTENDED TO BE MONITORED REGULARLY BY THE PRESCRIBING DENTIST ACCORDING TO THE PT'S INDIVIDUAL NEEDS. EVALUATION SUMMARY: ACCUTECH CUSTOM FABRICATES THE TAP 3 APPLIANCE ONLY ON THE WRITTEN PRESCRIPTION OF A DENTAL PROFESSIONAL. WE MANUFACTURE THE TAP 3 APPLIANCE UNDER THE UMBRELLA OF THE PMA 510(K) # K062951 OF AIRWAY MANAGEMENT, INC. WHO SELLS US LOT NUMBERED PACKAGES WHICH CONTAIN ALL THE PARTS NECESSARY TO CUSTOM ASSEMBLE THE TAP 3 APPLIANCE. BEFORE ENTERING INTO OUR AGREEMENT WITH AIRWAY MANAGEMENT, INC. WE WERE REQUIRED TO FABRICATE A TEST CASE OF THE TAP 3 APPLIANCE AND SUBMIT IT TO AIRWAY MANAGEMENT, INC. FOR EVALUATION. UPON EVALUATION OF THE APPLIANCE IN QUESTION, WE FOUND THE APPLIANCE TO BE FABRICATED TO THE DESIGN CONTROLS AND PARAMETERS PROVIDED BY AIRWAY MANAGEMENT, INC. IN SPITE OF THIS THE METAL PLATE WHICH RECEIVES THE HOOK DID DISLODGE FROM THE APPLIANCE AND WAS SWALLOWED BY THE PT.

    Description of Event or Problem · 1

    ACCUTECH WAS CONTACTED BY THE PRESCRIBING DENTIST WHO INFORMED US THAT THE METAL PLATE DISLODGED FROM THE APPLIANCE AND THE PT SWALLOWED IT AND THE PT LATER PASSED THE METAL PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317854 AMI TAP 3 APPLIANCE LRK AIRWAY MANAGEMENT INC.

    Patients

    Seq Age Sex Outcome Treatment
    1