BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP TM 4.7MM MTX, 10MM

    MDR report key: 10684371 · Received October 15, 2020

    Report

    Report Number
    0002023141-2020-01674
    Event Type
    Injury
    Date Received
    October 15, 2020
    Date of Event
    September 22, 2020
    Report Date
    October 15, 2020
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024018907
    PMA / PMN Number
    K132258
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). PATIENT WEIGHT IS NOT PROVIDED / UNKNOWN. 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 · 1

    DOCTOR REPORTS THAT THE TMMWB10 IMPLANT WAS PLACED (B)(6) 2020. ON (B)(6) 2020 PATIENT PRESENTED IN OFFICE AND THE IMPLANT HAD TO BE REMOVED DUE TO INFECTION. TOOTH SITE # 16. INFLAMMATION IS ALSO REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1146920 IMP TM 4.7MM MTX, 10MM DENTAL IMPLANT DZE ZIMMER DENTAL TMMWB10 1226431 00889024018907

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention