BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERLINE

    MDR report key: 2032674 · Received March 15, 2011

    Report

    Report Number
    3005503242-2011-00012
    Event Type
    Injury
    Date Received
    March 15, 2011
    Date of Event
    February 24, 2011
    Report Date
    March 1, 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 SPEC. 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

    PRODUCT WAS RETURNED AS AN IMPLANT FAILURE BECAUSE OF LACK OF INTEGRATION. BASED ON THE REPORT, THE PT HAD GOOD ORAL HYGIENE AND MODERATE BONE CONDITION. THE FIXTURE WAS PLACED WITH A ONE STAGE SURGERY IN TOOTH LOCATION #3. OSTEON WAS USED AS A BONE MATERIAL. THE DOCTOR INDICATED THAT THE DEVICE WAS NOT RECEIVED DAMAGED OR DEFECTIVE SUCH THAT IT WOLD NOT PERFORM AS INTENDED. THE PT OUTCOME WAS RECOVERED WITHOUT ANY COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPERLINE ENDOSSEOUS DENTAL IMPLANT DZE DENTIUM USA FX7008SW G23ZA020S

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention