BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP TM 6.0MM MTX, 11.5MM

    MDR report key: 18207444 · Received November 24, 2023

    Report

    Report Number
    0002023141-2023-03354
    Event Type
    Injury
    Date Received
    November 24, 2023
    Report Date
    November 23, 2023
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024018846
    PMA / PMN Number
    K132258
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER: (B)(4. G4: ADDITIONAL PMA/510(K) NUMBER ¿ 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 EXPERIENCED INFECTION AT IMPLANT TOOTH SITE #3. THEREFORE, THE IMPLANT WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260333 IMP TM 6.0MM MTX, 11.5MM DENTAL IMPLANT DZE ZIMMER DENTAL 1249151 00889024018846

    Patients

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