BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTIUM

    MDR report key: 2062464 · Received April 6, 2011

    Report

    Report Number
    3005503242-2011-00018
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    February 1, 2011
    Report Date
    March 14, 2011
    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 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, PT BONE CONDITION, PT ORAL HYGIENE, OR PT BEHAVIOR.

    Description of Event or Problem · 1

    THE PRODUCT WAS RETURNED AS AN IMPLANT FAILURE BECAUSE OF FAILURE TO OSSEOINTEGRATE. BASED ON THE REPORT, THE PT HAD GOOD ORAL HYGIENE AND GOOD BONE CONDITION. THE FIXTURE WAS PLACED WITH A TRADITIONAL 2 STAGE SURGERY AND FIXTURE WAS PLACED WITH PRIMARY CLOSURE IN TOOTH LOCATION #4. OSTEON WAS USED AS A BONE MATERIAL. THE IMPLANT WAS REMOVED BECAUSE OF THE BONE CONDITION. THE PT HAS NO MEDICAL HISTORY. THE DOCTOR INDICATED THAT THE DEVICE WAS NOT RECEIVED DAMAGED OR DEFECTIVE SUCH THAT IT WOULD NOT PERFORM AS INTENDED. THE PT 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 FX4312MLC I18Y06E01DR

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention