BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERLINE

    MDR report key: 2193305 · Received July 25, 2011

    Report

    Report Number
    3005503242-2011-00046
    Event Type
    Injury
    Date Received
    July 25, 2011
    Date of Event
    June 24, 2011
    Report Date
    June 27, 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 NINETY-FIVE PERCENT. THEREFORE, THE IMPLANT FAILURE IS MOST LIKELY DUE TO CAUSES OTHER THAN THE PRODUCT SUCH AS SURGICAL MISTAKE, PATIENT BONE CONDITION, PATIENT ORAL HYGIENE, OR PATIENT 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 PATIENT HAD GOOD ORAL HYGIENE AND MODERATE BONE CONDITION. THE PATIENT HAS A MEDICAL HISTORY OF TOBACCO. THE FIXTURE WAS PLACED IN TOOTH LOCATION #14. ALLOGRAFT WAS USED AS A BONE MATERIAL. IMPLANT WAS REMOVED BECAUSE THE IMPLANT HAD NOT INTEGRATED WELL AND BECAME LOOSE WHILE TIGHTENING THE ABUTMENT. THE DOCTOR INDICATED THAT THE DEVICE WAS NOT RECEIVED DAMAGED OR DEFECTIVE, SUCH THAT IT WOULD NOT PERFORM AS INTENDED. ANOTHER IMPLANT WAS PLACED AFTER 4 DAYS AT THE SAME SITE AFTER HEELING. THE PATIENT OUTCOME WAS REPORTED AS RECOVERED, NO COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPERLINE ENDOSSEOUS DENTAL IMPLANT DZE DENTIUM USA FX4512SWC F14XA109S

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention