BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP, TSV, 6.0, 10, MTXF, MG,HA

    MDR report key: 10436767 · Received August 21, 2020

    Report

    Report Number
    0002023141-2020-01273
    Event Type
    Injury
    Date Received
    August 21, 2020
    Date of Event
    December 2, 2019
    Report Date
    August 21, 2020
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024344242
    PMA / PMN Number
    K101880
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL 510(K) NUMBER IS K133339. 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 · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE IMPLANT SITE THAT REQUIRED ANTIBIOTICS. SITE WAS INFLAMED AND PATIENT WAS EXPERIENCING DISCOMFORT. PATIENT TO RETURN FOR ADDITIONAL APPOINTMENTS. TOOTH #3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    904503 IMP, TSV, 6.0, 10, MTXF, MG,HA DENTAL IMPLANT DZE ZIMMER DENTAL TSVT6H10 1219678 00889024344242

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention