BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP TM 4.7MM MTX, 10MM

    MDR report key: 14526075 · Received May 27, 2022

    Report

    Report Number
    0002023141-2022-01329
    Event Type
    Injury
    Date Received
    May 27, 2022
    Date of Event
    May 9, 2022
    Report Date
    May 27, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024018907
    PMA / PMN Number
    K132258
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (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

    IT WAS REPORTED THAT THE PATIENT'S CBCT SCAN INDICATED UNUSUAL PATTERN OF TRABECULAR BONE, DUE TO CHRONIC SINUSITIS ACCORDING TO RADIOLOGIST. THE IMPLANT WAS REMOVED DUE TO AN INFECTION. TOOTH #3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2115147 IMP TM 4.7MM MTX, 10MM DENTAL IMPLANT DZE ZIMMER DENTAL TMMWB10 1245746 00889024018907

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention