BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTIUM

    MDR report key: 1911383 · Received November 24, 2010

    Report

    Report Number
    3005503242-2010-00089
    Event Type
    Injury
    Date Received
    November 24, 2010
    Date of Event
    December 9, 2009
    Report Date
    October 28, 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. IMPLANT FAILURE 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. THE FIXTURE WAS NOT DAMAGED IN SUCH A WAY THAT IT WOULD CAUSE IMPLANT FAILURE.

    Description of Event or Problem · 1

    BASED ON THE REPORT, THE PRODUCT WAS RETURNED AS AN IMPLANT FAILURE BECAUSE OF PAIN AND ABNORMAL SENSATION AFTER OVER 1 YEAR. BASED ON THE REPORT, THE PT HAD GOOD ORAL HYGIENE AND MODERATE BONE CONDITION. THE FIXTURE WAS PLACED WITH A TRADITIONAL 2 STAGE SURGERY IN TOOTH LOCATION #29. A SINGLE PROSTHETIC WAS USED. BIO-OSS BONE MATERIAL WAS USED. THE DOCTOR INDICATED THAT THE DEVICE WAS NOT REC'D 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 DZE DENTIUM USA FX3812MLC 0810402

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention