BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP TM 4.1MM MTX,11.5MM

    MDR report key: 18411341 · Received December 28, 2023

    Report

    Report Number
    0002023141-2023-03653
    Event Type
    Injury
    Date Received
    December 28, 2023
    Date of Event
    October 10, 2023
    Report Date
    December 27, 2023
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024018815
    PMA / PMN Number
    K132258
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT (B)(4). G4: 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 PATIENT COMPLAINED FOR AREA BEING SORE AND ACHY, PA REVEALED INFECTION AROUND IMPLANT SITE. IMPLANT WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, ABSCESS. TOOTH NUMBER: 11 UNIVERSAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1530933 IMP TM 4.1MM MTX,11.5MM DENTAL IMPLANT DZE ZIMMER DENTAL 1255586 00889024018815

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male Required Intervention