BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTIUM

    MDR report key: 1944494 · Received December 23, 2010

    Report

    Report Number
    3005503242-2010-00101
    Event Type
    Injury
    Date Received
    December 23, 2010
    Date of Event
    November 22, 2010
    Report Date
    November 24, 2010
    Manufacturer
    DENTIUM USA
    Product Code
    DZE
    PMA / PMN Number
    K041368
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON INSPECTION RESULTS AND THE DHR REVIEW, THE RETURNED PRODUCT HAS BEEN FOUND TO BE WITHIN SPECIFICATION. LACK OF OSSEOINTEGRATION IS A KNOWN ADVERSE EFFECT FOR ALL DENTAL IMPLANTS AS STATED IN OUR IFU. THE OVERALL SUCCESS RATE FOR DENTAL IMPLANTS IS ABOUT 95%. 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. ADDITIONALLY, THE PATIENT WAS A REPORTED TOBACCO USER AND TO HAVE ONLY MODERATED ORAL HYGIENE AND MODERATE BONE CONDITION.

    Description of Event or Problem · 1

    BASED ON THE REPORT, THE PRODUCT WAS RETURNED AS AN IMPLANT FAILURE BECAUSE OF LACK OF OSSEOINTEGRATION AND AN INFECTION. BASED ON THE REPORT, THE PATIENT HAD MODERATE ORAL HYGIENE AND MODERATE BONE CONDITION. THE FIXTURE WAS PLACED WITH A TRADITIONAL TWO STAGE SURGERY IN TOOTH LOCATION #13. NO BONE MATERIAL WAS USED. THE DOCTOR INDICATED THAT THE DEVICE WAS NOT RECEIVED DAMAGED OR DEFECTIVE SUCH THAT IT WOULD NOT PERFORM AS INTENDED. THE PATIENT OUTCOME WAS REPORTED AS RECOVERED WITH NO COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPLANTIUM ENDOSSEOUS DENTAL IMPLANT DZE DENTIUM USA FX4310MLC K02Y06F26AS

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention