BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,6.0,13,MTX,MG

    MDR report key: 10733549 · Received October 26, 2020

    Report

    Report Number
    0002023141-2020-01777
    Event Type
    Injury
    Date Received
    October 26, 2020
    Date of Event
    September 29, 2020
    Report Date
    October 26, 2020
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019898
    PMA / PMN Number
    K101977
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). INITIAL REPORTER¿S FIRST NAME IS NOT PROVIDED / UNKNOWN. ADDITIONAL 510(K) NUMBER IS K101880.

    Description of Event or Problem · 1

    DOCTOR REPORTS THEY WERE UNABLE TO ACHIEVE PRIMARY STABILITY WITH THE TSVT6B13 IMPLANT. TOOTH SITE # 18. SITE WAS GRAFTED PRIOR TO PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1201804 IMP,TSV,6.0,13,MTX,MG DENTAL IMPLANT DZE ZIMMER DENTAL TSVT6B13 1220485 00889024019898

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR