BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP TM 4.1MM MTX FULL,13M

    MDR report key: 12843777 · Received November 19, 2021

    Report

    Report Number
    0002023141-2021-03341
    Event Type
    Injury
    Date Received
    November 19, 2021
    Date of Event
    October 12, 2021
    Report Date
    November 19, 2021
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024018952
    PMA / PMN Number
    K132258
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). ADDITIONAL 510(K) NUMBERS ARE K113753 AND K112160. 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

    IMPLANT AT TOOTH SITE # 13 (UNIVERSAL) WAS TORQUE TESTED SUCCESSFULLY AND IT WAS INTEGRATED, HOWEVER THERE WAS A LARGE AMOUNT OF GRANULATION TISSUE STILL PRESENT CIRCUMFERENTIALLY AROUND THE IMPLANT. IMPLANT WAS REMOVED DUE TO INFECTION. THE SITE WAS GRAFTED TOGETHER WITH ORIGINAL IMPLANT PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1743867 IMP TM 4.1MM MTX FULL,13M DENTAL IMPLANT DZE ZIMMER DENTAL TMT4B13 1226159 00889024018952

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female Required Intervention