BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERLINE

    MDR report key: 2234087 · Received August 29, 2011

    Report

    Report Number
    3005503242-2011-00064
    Event Type
    Injury
    Date Received
    August 29, 2011
    Date of Event
    August 4, 2011
    Report Date
    August 8, 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 INTEGRATE. BASED ON THE REPORT, THE PT HAD GOOD ORAL HYGIENE AND GOOD BONE CONDITION. TRADITIONAL 2 STATE SURGERY WAS DONE. FIXTURE WAS PLACED IN TOOTH LOCATION #19. NO BONE AUGMENTATION MATERIAL WAS USED. THE IMPLANT WAS REMOVED BECAUSE OF INFECTION. 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 STABLE HOWEVER TREATMENT WAS ONGOING. ANOTHER IMPLANT WILL BE PLACED IN 4 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPERLINE ENDOSSEOUS DENTAL IMPLANT DZE DENTIUM USA FX3612SWC G087YA065S

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention