BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP, TSV, 4.7,11,MTX,MC,MG,HA

    MDR report key: 21770249 · Received April 3, 2025

    Report

    Report Number
    0002023141-2025-00879
    Event Type
    Injury
    Date Received
    April 3, 2025
    Date of Event
    February 23, 2025
    Report Date
    April 2, 2025
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024344150
    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 NUMBER: (B)(4). G4: ADDITIONAL PMA/510(K) NUMBER ¿ 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 AT TOOTH SITE #5 WAS REMOVED DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2371216 IMP, TSV, 4.7,11,MTX,MC,MG,HA DENTAL IMPLANT DZE ZIMMER DENTAL 63535595 00889024344150

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention