BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FULL OSSEOTITE® IMPLANT 4 X 7MM

    MDR report key: 24950071 · Received April 22, 2026

    Report

    Report Number
    0001038806-2026-02189
    Event Type
    Injury
    Date Received
    April 22, 2026
    Date of Event
    January 15, 2025
    Report Date
    April 22, 2026
    Manufacturer
    ZIMVIE US CORP LLC
    Product Code
    DZE
    PMA / PMN Number
    K063286
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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. D9: DEVICE AVAILABILITY UNKNOWN / NOT PROVIDED. 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 IMPLANT AT TOOTH SITE 22 WAS REMOVED DUE TO PERI-IMPLANTITIS WITH TOTAL LOSS OF INTEGRATION. PATIENT HAS BEEN SCHEDULED FOR NEW IMPLANT PLACEMENT IN APROXIMATELY 3 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199575 FULL OSSEOTITE® IMPLANT 4 X 7MM DENTAL IMPLANT DZE ZIMVIE US CORP LLC 2011040055

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male Required Intervention