BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP TM 4.7MM MTX, 10MM

    MDR report key: 19843270 · Received July 26, 2024

    Report

    Report Number
    0002023141-2024-02576
    Event Type
    Injury
    Date Received
    July 26, 2024
    Date of Event
    June 23, 2024
    Report Date
    July 25, 2024
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024018907
    PMA / PMN Number
    K132258
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). A2: AGE AND DATE OF BIRTH UNKNOWN/NOT PROVIDED. A3: GENDER UNKNOWN/NOT PROVIDED. A4: PATIENT WEIGHT UNKNOWN/NOT PROVIDED. G4: PMA/510(K) NUMBERS: 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 · 0

    IT WAS REPORTED THAT THE PATIENT RETURNED 3 WEEKS AFTER IMPLANT PLACEMENT WITH SWELLING IN THE FACE. EXAM REFLECTED PUS DRAINAGE AROUND IMPLANT AT TOOTH SITE # UNKNOWN. SYMPTOMS AS A RESULT OF THE EVENT: DRAINAGE. INFLAMMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561619 IMP TM 4.7MM MTX, 10MM DENTAL IMPLANT DZE ZIMMER DENTAL 1268501 00889024018907

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Required Intervention