BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTIUM

    MDR report key: 1705256 · Received May 28, 2010

    Report

    Report Number
    3005503242-2010-00035
    Event Type
    Injury
    Date Received
    May 28, 2010
    Date of Event
    January 7, 2010
    Report Date
    April 30, 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

    CONCLUSION: BASED ON INSPECTION AND TEST RESULTS, THE RETURNED PRODUCT HAS BEEN FOUND TO BE WITHIN SPECIFICATIONS. THEREFORE, THE IMPLANT FAILURE IS MOST LIKELY DUE TO CAUSES OTHER THAN THE PRODUCT SUCH AS SURGICAL MISTAKE, PT BONE CONDITION, PT ORAL HYGIENE, OR PT BEHAVIOR.

    Description of Event or Problem · 1

    PRODUCT WAS RETURNED AS AN IMPLANT FAILURE BECAUSE IT WAS LOOSE. BASED ON THE REPORT, THE PT HAD GOOD ORAL HYGIENE AND GOOD BONE CONDITION. THE SURGERY WAS A TRADITIONAL 2 STAGE SURGERY IN TOOTH LOCATION #3. BONE AUGMENTATION MATERIAL "MIF" WAS USED. THE IMPLANT WAS REMOVED BECAUSE OF MOBILITY. THE PT IS DESCRIBED AS RECOVERED WITH NO COMPLICATIONS. THE DOCTOR INDICATED THAT THE DEVICE WAS NOT RECEIVED DAMAGED OR DEFECTIVE SUCH THAT IT WOULD NOT PERFORM AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPLANTIUM ENDOSSEOUS DENTAL IMPLANT DZE DENTIUM USA FX4310MLC A07Y06H01AR

    Patients

    Seq Age Sex Outcome Treatment
    1 Congenital Anomaly| R