BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSSEOTITE TAPERED CERTAIN PREVAIL IMPLANT 4/3 X 13MM

    MDR report key: 23174012 · Received September 29, 2025

    Report

    Report Number
    0001038806-2025-02274
    Event Type
    Injury
    Date Received
    September 29, 2025
    Date of Event
    July 3, 2025
    Report Date
    September 29, 2025
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    PMA / PMN Number
    K130949
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). A4: WEIGHT UNKNOWN / NOT PROVIDED. G4: ADDITIONAL PMA/510(K) NUMBER ¿ K130949. A SUMMARY INVESTIGATION HAS BEEN COMPLETED FOR BONE LOSS AND INFECTION 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 BONE LOSS AND INFECTION HAVE NOT IDENTIFIED ANY SIGNALS INDICATING POTENTIAL NON-CONFORMANCES AFFECTING THE MANUFACTURING AND STERILIZATION PROCESSES. FURTHERMORE, THE PROBABILITY OF MANUFACTURING OR DESIGN DEFECTS THAT MIGHT LEAD TO BONE LOSS 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 THAT THE IMPLANT WAS PLACED USING SURGICAL TOOTH-BORNE GUIDE. THIS WAS AN IMMEDIATE IMPLANT PLACED AT THE TIME OF THE EXTRACTION AT TOOTH SITE #10. DURING THE POST-OPERATIVE EXAMINATION, TWO WEEKS AFTER THE PROCEDURE, IT WAS NOTED THAT THE HEALING WAS NORMAL WITH SOFT TISSUE MOSTLY COVERING THE TOOTH SITE, EXCEPT FOR A SMALL GAP AT THE CREST. THE PATIENT REPORTED THAT THE IMPLANT HAD CAME OUT OF HIS MOUTH ON (B)(6) 2025. THEY PRESENTED TO THE DENTAL OFFICE AND IT WAS CONFIRMED THAT THERE WAS A SMALL GAP AT THE CREST OF THE TOOTH SITE AND THAT IT WAS BLEEDING, BUT THERE WAS NO EXUDATE. IMAGING CONFIRMED EXTENSIVE BONE LOSS AT THE SITE. A BONE GRAFT WAS PERFORMED ON THE SITE IN PREPARATION FOR AN IMPLANT REPLACEMENT AT A LATER, UNCONFIRMED DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1840100 OSSEOTITE TAPERED CERTAIN PREVAIL IMPLANT 4/3 X 13MM DENTAL IMPLANT DZE BIOMET 3I 2022071101

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Required Intervention