BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STABLEDENT SNAP CAP

    MDR report key: 1507555 · Received September 30, 2009

    Report

    Report Number
    1065595-2009-10004
    Event Type
    Malfunction
    Date Received
    September 30, 2009
    Date of Event
    June 19, 2008
    Report Date
    June 21, 2008
    Manufacturer
    FOLSOM METAL PRODUCTS, INC.
    Product Code
    GCZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER DID NOT NECESSARILY FEEL THIS WAS AN ADVERSE EVENT. HOWEVER, ALL CAPA PROCEDURES WERE COMPLETED TO VERIFY THE PATIENT SAFETY.

    Description of Event or Problem · 1

    ON (B)(6) 2008, DR (B)(6) PHONED IN A COMPLAINT TO OUR FIRM ((B)(4)) STATING THAT TWO IMPLANT SNAP CAPS IN THE LOWER MANDIBLE HAD WORN OUT AND LOST RETENTION AFTER FOUR (4) WEEKS. HE HAD REPLACED THE SNAP CAPS THAT HAD WORN, HOWEVER, THE NEW ONES WORE OUT AGAIN THIS TIME ONLY AFTER TWO (2) WEEKS. HE WAS CONCERNED AS TO WHY THIS WAS HAPPENING, AND WANTED TO SEE WHAT TYPE OF INTERVENTION NEEDED TO TAKE PLACE TO PREVENT THE PATIENT FROM EXPERIENCING ANY ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STABLEDENT SNAP CAP GCZ- RETAINER GCZ FOLSOM METAL PRODUCTS, INC. I02201

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention