BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP, TSV, 4.7, 8,MTX,MC,MG,HA

    MDR report key: 16894878 · Received May 9, 2023

    Report

    Report Number
    0002023141-2023-01287
    Event Type
    Injury
    Date Received
    May 9, 2023
    Date of Event
    March 20, 2023
    Report Date
    May 9, 2023
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024344181
    PMA / PMN Number
    K101880
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT (B)(4). ADDITIONAL 510(K) NUMBER IS K133339. A SUMMARY INVESTIGATION HAS BEEN COMPLETED FOR INFECTION EVENTS IDENTIFYING THAT A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED DUE TO THE WIDE RANGE OF EXTERNAL (NON-DESIGN/ NON-MANUFACTURING RELATED) FACTORS POTENTIALLY IMPACTING THE STERILITY OF THE IMPLANT AND ITS ENVIRONMENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED WHICH INDICATES THAT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE INFECTION EVENT, AN ADDITIONAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO MEDICAL INFECTION. TOOTH SITE # 19 (UNIVERSAL). THE SITE WAS GRAFTED WITH ALLOGRAFT TOGETHER WITH ORIGINAL IMPLANT PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1877334 IMP, TSV, 4.7, 8,MTX,MC,MG,HA DENTAL IMPLANT DZE ZIMMER DENTAL TSVMWH8 1260683 00889024344181

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention