BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP TM 4.7MM MTX FULL, 10

    MDR report key: 10227772 · Received July 3, 2020

    Report

    Report Number
    0002023141-2020-00986
    Event Type
    Injury
    Date Received
    July 3, 2020
    Date of Event
    March 9, 2020
    Report Date
    July 2, 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 NUMBER (B)(4). WEIGHT UNKNOWN / NOT PROVIDE. PMA/510(K): K113753, 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

    IT WAS REPORTED THAT IMPLANT AT TOOTH SITE # 31 WAS REMOVED DUE TO INFECTION. IMPLANT WAS REMOVED AND SITE GRAFTED. SYMPTOMS AS A RESULT OF THE EVENT: INFECTION AND PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694661 IMP TM 4.7MM MTX FULL, 10 DENTAL IMPLANT DZE ZIMMER DENTAL TMTWB10 1231424 00889024019034

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention