BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NANOTITE TM CERTAIN® IMPLANT 5 X 11.5MM

    MDR report key: 3951290 · Received July 22, 2014

    Report

    Report Number
    0001038806-2014-00088
    Event Type
    Injury
    Date Received
    July 22, 2014
    Date of Event
    June 7, 2012
    Report Date
    June 4, 2014
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    PMA / PMN Number
    PK051461
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: 3I NIOSS511 IMPLANT WAS NOT RETURNED 07/18/14 (DISCARDED), THEREFORE, COMPLAINT CANNOT BE VERIFIED WHY RESTORATIVE DENTIST WAS UNABLE TO FULLY SEAT FINAL ABUTMENTS. NO CONCLUSION CAN BE DRAWN. CHECKED INVENTORY AND ALL 237 / NIOSS511 FROM THIS LOT HAVE BEEN SHIPPED AND THIS IS THE ONLY REPORTED SEATING ISSUES AND THE 8TH REPORTED INCIDENT TO DATE. OTHER INCIDENTS WERE FOR LOSS / NON-INTEGRATION. THE REVIEW OF THE DHR RECORDS DID NOT PROVIDE ANY INDICATION OF A MANUFACTURING DEVIATION THAT WOULD CAUSE THIS CONDITION.

    Description of Event or Problem · 1

    THE DOCTOR (ORAL SURGEON) INDICATED THAT THE IMPLANT INTEGRATED NORMALLY, BUT THE RESTORATIVE DENTIST WAS UNABLE TO FULLY SEAT FINAL ABUTMENTS. THE RESTORATIVE DENTIST ATTEMPTED TO SEAT TWO ABUTMENTS WITHOUT SUCCESS, THE IMPLANT WAS DEEMED NON-FUNCTIONAL AND WAS REMOVED. IMPLANT REMOVED BY TREPHINE BUR AND THE SITE WAS GRAFTED FOR FUTURE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428525 NANOTITE TM CERTAIN® IMPLANT 5 X 11.5MM NANOTITE TM CERTAIN® IMPLANT 5 X 11.5MM DZE BIOMET 3I N/A 972866

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention