BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,6.0,11.5,MTX,MG

    MDR report key: 22025059 · Received May 15, 2025

    Report

    Report Number
    0002023141-2025-01275
    Event Type
    Injury
    Date Received
    May 15, 2025
    Date of Event
    April 2, 2025
    Report Date
    May 14, 2025
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019881
    PMA / PMN Number
    K101977
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). A4: PATIENT WEIGHT UNKNOWN / NOT PROVIDED. G4: PREMARKET IDENTIFICATION K101977/K101880. 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

    DOCTOR REPORTED THE LOOSE IMPLANT WITH BONE LOSS. THE IMPLANT WAS REMOVED. GRAFTED: ALLOGRAFT. TOOTH SITE: 30.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1825182 IMP,TSV,6.0,11.5,MTX,MG DENTAL IMPLANT DZE ZIMMER DENTAL 1235705 00889024019881

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female