BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSSEOTITE CERTAIN IMPLANT 4 X 11.5MM

    MDR report key: 18425242 · Received January 2, 2024

    Report

    Report Number
    0001038806-2024-02541
    Event Type
    Injury
    Date Received
    January 2, 2024
    Date of Event
    April 23, 2023
    Report Date
    January 1, 2024
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    PMA / PMN Number
    K063341
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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 IOSS485, OSSEOTITE CERTAIN IMPLANT 4 X 8.5MM, LOT NUMBER: 840841 E1: REPORTER PHONE: +(B)(6). 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

    DOCTOR REPORTED THAT IMPLANTS AT TOOTH SITES 45, 47 WERE REMOVED DUE TO PERI-IMPLANTITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1262142 OSSEOTITE CERTAIN IMPLANT 4 X 11.5MM DENTAL IMPLANT DZE BIOMET 3I 2008080039

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female DENTAL IMPLANT