BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSSEOTITE TAPERED IMPLANT 4 X 8.5MM

    MDR report key: 20479592 · Received October 18, 2024

    Report

    Report Number
    0001038806-2024-02355
    Event Type
    Injury
    Date Received
    October 18, 2024
    Date of Event
    September 16, 2024
    Report Date
    October 17, 2024
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    PMA / PMN Number
    K063286
    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). D4: UNIQUE IDENTIFIER (UDI) NUMBER NOT AVAILABLE. D10. CONCOMITANT MEDICAL PRODUCTS NT485, OSSEOTITE TAPERED IMPLANT 4 X 8.5MM LOT 181351. 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

    DURING A REVIEW AND RADIOLOGICAL CONTROL, SIGNIFICANT BONE LOSS AND INFLAMMATORY TISSUE AROUND THE IMPLANTS WERE DETECTED. DENTIST REPORTED A PERIIMPLANTITIS AT TOOTH SITE #36 AND #37. NO IMPACT ON THE PATIENT REPORTED. IMPLANTS WERE REMOVED. BONE DENSITY: II.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2208923 OSSEOTITE TAPERED IMPLANT 4 X 8.5MM DENTAL IMPLANT DZE BIOMET 3I 181351

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male DENTAL IMPLANT SEE H10 NARRATIVE