BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZTETIC DENTAL IMPLANT, 3.1MM DIAMETER, 2.9MMD PLATFORM, 11.5MM LENGTH

    MDR report key: 19999058 · Received August 18, 2024

    Report

    Report Number
    0002023141-2024-02718
    Event Type
    Injury
    Date Received
    August 18, 2024
    Date of Event
    April 25, 2024
    Report Date
    January 13, 2025
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024343887
    PMA / PMN Number
    K142082
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). A4: PATIENT WEIGHT UNKNOWN / NOT PROVIDED. E1: FIRST NAME UNKNOWN / NOT PROVIDED. E1: LAST NAME UNKNOWN / NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). THE FOLLOWING FIELDS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT B5: DESCRIBE EVENT OR PROBLEM D9: DEVICE AVAILABILITY G3: DATE RECEIVED BY MANUFACTURER G6: TYPE OF REPORT H1: TYPE OF REPORTABLE EVENT H2: FOLLOW UP TYPE H3: DEVICE EVALUATED BY MANUFACTURER H6: ADVERSE EVENT PROBLEM H10: ADDITIONAL NARRATIVE. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1242327. NO DEVIATIONS OR NON-CONFORMANCES, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WERE NOTED AS PART OF THE DHR. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER 1242327 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: BONE LOSS. A SUMMARY INVESTIGATION HAS BEEN COMPLETED FOR BONE LOSS 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 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 AT TOOTH SITE #20 WAS REMOVED DUE TO BONE LOSS.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    992545 EZTETIC DENTAL IMPLANT, 3.1MM DIAMETER, 2.9MMD PLATFORM, 11.5MM LENGTH DENTAL IMPLANT DZE ZIMMER DENTAL 1242327 00889024343887

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male Required Intervention