BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTIUM

    MDR report key: 1771985 · Received July 22, 2010

    Report

    Report Number
    3005503242-2010-00056
    Event Type
    Injury
    Date Received
    July 22, 2010
    Date of Event
    June 5, 2010
    Report Date
    June 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 SPECIFICATION. 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

    PRODUCT WAS RETURNED AS AN IMPLANT FAILURE BECAUSE OF INFECTION. DOCTOR STATED "DID NOT INTEGRATE WITH BONE". BASED ON THE REPORT, THE PATIENT HAD MODERATE ORAL HYGIENE AND MODERATE BONE CONDITION. THE FIXTURE WAS PLACED WITH A TRADITIONAL 2-STAGE SURGERY IN TOOTH LOCATION #18. THE DOCTOR INDICATED THAT THE DEVICE WAS NOT RECEIVED DAMAGED OR DEFECTIVE SUCH THAT IT WOULD NOT PERFORM AS INTENDED. THE PATIENT'S OUTCOME WAS REPORTED AS RECOVERED, NO COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPLANTIUM ENDOSSEOUS DENTAL IMPLANT DZE DENTIUM USA FX6012SW H05ZA028S

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention