BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DENTAL IMPLANT

    MDR report key: 23976137 · Received January 6, 2026

    Report

    Report Number
    0001038806-2026-00057
    Event Type
    Injury
    Date Received
    January 6, 2026
    Date of Event
    September 29, 2025
    Report Date
    February 6, 2026
    Manufacturer
    ZIMVIE US CORP LLC
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). A1: PATIENT IDENTIFIER UNKNOWN / NOT PROVIDED. A4: WEIGHT UNKNOWN / NOT PROVIDED. D4: LOT NUMBER UNKNOWN / NOT PROVIDED. 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.

    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. G3: DATE RECEIVED BY MANUFACTURER. G6: TYPE OF REPORT. H1: TYPE OF REPORTABLE EVENT. H2: FOLLOW UP TYPE. H10: ADDITIONAL NARRATIVE. THIS SUPPLEMENTAL IS BEING REPORTED AS RETRACTION SINCE THIS EVENT WAS INITIALLY CREATED/SUBMITTED TO FDA UNDER SUBMISSION SITE ZIMVIE US CORP LLC ON JANUARY 06, 2026, WITH MFR NUMBER 0001038806-2026-00057. AFTER NEW INFORMATION WAS RECEIVED ON FEBRUARY 04, 2026, IT WAS DETERMINED THAT THE PRODUCT WAS NOT MANUFACTURED BY ZIMVIE US CORP LLC, AND IS A THIRD PARTY DEVICE. AS A RESULT, THIS IS NO LONGER CONSIDERED A REPORTABLE EVENT BY ZIMVIE AND NO FURTHER REPORT WILL BE SUBMITTED FOR THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT CAME TO MEDICAL OFFICE WITH DISCOMFORT AND FISTULA, AFTER X-RAY BONE LOSS NOTICED AND IMPLANT WAS REMOVED. PATIENT HAD TO RETURN TO PLACE A NEW IMPLANT AT TOOTH SITE #13.

    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
    34558 DENTAL IMPLANT DZE ZIMVIE US CORP LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Unknown Required Intervention