BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTIUM

    MDR report key: 1905720 · Received November 9, 2010

    Report

    Report Number
    3005503242-2010-00087
    Event Type
    Injury
    Date Received
    November 9, 2010
    Date of Event
    October 13, 2010
    Report Date
    October 26, 2010
    Manufacturer
    DENTIUM USA
    Product Code
    HAW
    PMA / PMN Number
    K041369
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: VISUAL EXAMINATION WAS ACCEPTABLE, SLA SURFACE TREATMENT WAS CONFIRMED. NO OBVIOUS DAMAGE OR OTHER ABNORMALITY WAS OBSERVED. AS A RESULT OF A RE-INSPECTION, THE PRODUCT WAS CONFIRMED TO BE MODEL FX4812MLC AND MEETS ALL DIMENSIONAL SPECIFICATIONS. DHR REVIEW FOR LOT# 08B1201 FOUND RELEASED DEVICES TO MEET SPECIFICATIONS. NOTHING IN THE RECORD INDICATED CAUSE FOR THIS COMPLAINT. 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

    BASED ON THE REPORT, THE PRODUCT WAS RETURNED AS AN IMPLANT FAILURE BECAUSE OF LACK OF OSSEOINTEGRATION DUE TO AN INFECTION. BASED ON THE REPORTER, THE PT HAD GOOD ORAL HYGIENE AND GOOD BONE CONDITION. THE FIXTURE WAS PLACED WITH PRIMARY CLOSURE SURGERY IN TOOTH LOCATION #8. 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 PT OUTCOME WAS REPORTED AS RECOVERED, NO COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPLANTIUM ENDOSSEOUS DENTAL IMPLANT HAW DENTIUM USA FX4812MLC 08B1201

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention