BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP TM 4.7MM MTX FULL, 10

    MDR report key: 16292615 · Received February 3, 2023

    Report

    Report Number
    0002023141-2023-00409
    Event Type
    Injury
    Date Received
    February 3, 2023
    Date of Event
    December 20, 2022
    Report Date
    February 1, 2023
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019034
    PMA / PMN Number
    K132258
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). PMA/510K: 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

    CUSTOMER REPORTED THAT THE PATIENT CAME COMPLAINING OF PAIN. XRAY TAKEN REVEALS PERIAPICAL LESION UNDER IMPLANT #18. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785676 IMP TM 4.7MM MTX FULL, 10 DENTAL IMPLANT DZE ZIMMER DENTAL TMTWB10 1230191 00889024019034

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Required Intervention