BEUDAMED
    FDA Adverse Event Other Summary report: N

    UF IMPLANT SYSTEM

    MDR report key: 3313580 · Received August 19, 2013

    Report

    Report Number
    3006113174-2013-00031
    Event Type
    Other
    Date Received
    August 19, 2013
    Date of Event
    July 22, 2013
    Report Date
    August 19, 2013
    Manufacturer
    DIO CORPORATION
    Product Code
    DZE
    PMA / PMN Number
    K122519
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: BASED ON INSPECTION RESULTS AND THE DHR REVIEW, THE RETURNED PVD DUCT HAS BEEN FOUND TO BE WITHIN SPEC. THEREFORE, THE IMPLANT FAILURE IS MOST LIKELY DUE TO CAUSES OTHER THAN PRODUCT, SUCH AS SURGICAL MISTAKE, PT MEDICAL HISTORY, BONE CONDITION, OR PT BEHAVIOUR.

    Description of Event or Problem · 1

    THE PT DEVELOPED ON INFECTION IN TOOTH LOCATION #36 AND THE DOCTOR REPORTED THE FIXTURE WAS LOOSING AFTER BEING IMPLANTED FOR 3 MONTHS. DENTIST INDICATED INFECTION AS CONTRIBUTING FACTOR FOR REMOVAL OF IMPLANT PT HAS POOR ORAL HYGIENE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399435 UF IMPLANT SYSTEM DZE DIO CORPORATION UF 4011S 120822P39

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention