BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSSEOTITE TAPERED CERTAIN IMPLANT 4 X 11.5MM

    MDR report key: 11663801 · Received April 14, 2021

    Report

    Report Number
    0001038806-2021-00608
    Event Type
    Injury
    Date Received
    April 14, 2021
    Date of Event
    March 15, 2021
    Report Date
    April 14, 2021
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    UDI-DI
    00844868021964
    PMA / PMN Number
    K130949
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). 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 · 1

    IT WAS REPORTED PERI-IMPLANTITIS ON THE VESTIBULAR BONE WALL WITH GREAT RECESSION. DOCTOR PERFORMED GUIDED BONE REGENERATION IN BONE AND MEMBRANE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564347 OSSEOTITE TAPERED CERTAIN IMPLANT 4 X 11.5MM DENTAL IMPLANT DZE BIOMET 3I XIFNT411 2018110819 00844868021964

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention