BEUDAMED
    FDA Adverse Event Other Summary report: N

    SM IMPLANT SYSTEM

    MDR report key: 3144975 · Received May 28, 2013

    Report

    Report Number
    3006113174-2013-00011
    Event Type
    Other
    Date Received
    May 28, 2013
    Date of Event
    April 26, 2013
    Report Date
    May 27, 2013
    Manufacturer
    DIO CORP.
    Product Code
    DZE
    PMA / PMN Number
    K080559
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INSPECTION RESULTS AND DHR REVIEW, THE RETURNED PRODUCT HAS BEEN FOUND TO BE WITHIN SPECIFICATION. FAILURE TO OSSEOINTEGRATE IS A WELL-KNOWN INHERENT RISK OF DENTAL IMPLANTS. THIS IS WELL DOCUMENTED IN THE LITERATURE ACROSS THE IMPLANT SYSTEM. THEREFORE, THE IMPLANT FAILURE IS MOST LIKELY DUE TO CAUSES OTHER THAN THE PRODUCT SUCH AS SURGICAL MISTAKE, PATIENT BONE CONDITION, PATIENT ORAL HYGIENE, OR PATIENT BEHAVIOR.

    Description of Event or Problem · 1

    IN THIS EVENT, IT WAS REPORTED THAT SM DENTAL IMPLANTS FAILED TO OSSEOINTEGRATE. ON (B)(6) 2013, THE DENTIST DECIDED TO REMOVE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232877 SM IMPLANT SYSTEM DZE DIO CORP. SFR 5012 KR110316P4

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Other