BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP TM 4.7MM MTX FULL, 10

    MDR report key: 10258117 · Received July 10, 2020

    Report

    Report Number
    0002023141-2020-01030
    Event Type
    Injury
    Date Received
    July 10, 2020
    Date of Event
    March 11, 2020
    Report Date
    July 10, 2020
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019034
    PMA / PMN Number
    K132258
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). PATIENT IDENTIFIER IS NOT PROVIDED / UNKNOWN. 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 PATIENT PRESENTED IN OFFICE DUE TO BUBBLE ON GUM TISSUE. DOCTOR OPENED AND INFECTION WAS PRESENT. THE TMTWB10 IMPLANT WAS REMOVED. ABSCESS, INFLAMMATION AND PAIN IS ALSO REPORTED. TOOTH SITE #30. SITE WAS GRAFTED PRIOR TO PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724296 IMP TM 4.7MM MTX FULL, 10 DENTAL IMPLANT DZE ZIMMER DENTAL TMTWB10 1231424 00889024019034

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention