BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NANOTITE TM TAPERED CERTAIN PREVAIL IMPLANT 4/3 X 10MM

    MDR report key: 19079491 · Received April 10, 2024

    Report

    Report Number
    0001038806-2024-00701
    Event Type
    Injury
    Date Received
    April 10, 2024
    Date of Event
    October 15, 2023
    Report Date
    April 9, 2024
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    PMA / PMN Number
    K063341
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). A4: PATIENT WEIGHT UNKNOWN/NOT PROVIDED. D4: UNIQUE IDENTIFIER (UDI) NUMBER NOT AVAILABLE. D10: CONCOMITANT MEDICAL PRODUCT AND THERAPY DATES: NIITP4310, NANOTITE TM TAPERED CERTAIN PREVAIL IMPLANT 4/3 X 10MM, LOT NUMBER: 843451. A SUMMARY INVESTIGATION HAS BEEN COMPLETED FOR PERI-IMPLANTITIS EVENTS RECOGNIZING THAT A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED DUE TO A WIDE RANGE OF EXTERNAL FACTORS (NON-DESIGN OR MANUFACTURING RELATED), INCLUDING MEDICAL CONDITIONS (E.G., DIABETES, POOR BONE QUALITY, ETC.)/ PATIENT HABITS (E.G., SMOKING) AND SURGICAL TECHNIQUE. PREVIOUSLY COMPLETED INVESTIGATIONS FOR THESE EVENTS HAVE NOT IDENTIFIED ANY SIGNALS INDICATING POTENTIAL NON-CONFORMANCES AFFECTING THE MANUFACTURING AND STERILIZATION PROCESSES. FURTHERMORE, THE PROBABILITY OF A MANUFACTURING OR DESIGN DEFECT THAT MIGHT LEAD TO PERI-IMPLANTITIS OCCURRING AND ESCAPING THE AVAILABLE DETECTIONS HAS BEEN ASSESSED AND FOUND REMOTE AND ALMOST NONEXISTENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED WHICH INDICATES THAT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AN ADDITIONAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED A BONE LOSS AT TOOTH SITES 33 - 35. HYBRID PROSTHESIS CARRIER HAS PRESENTED PERI-IMPLANT BONE LOSS. PATIENT SUFFERED INFLAMMATION. IMPLANTS WERE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407108 NANOTITE TM TAPERED CERTAIN PREVAIL IMPLANT 4/3 X 10MM DENTAL IMPLANT DZE BIOMET 3I 895197

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female DENTAL IMPLANT.