BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,4.7,8,MTX,MG

    MDR report key: 15225008 · Received August 15, 2022

    Report

    Report Number
    0002023141-2022-02054
    Event Type
    Injury
    Date Received
    August 15, 2022
    Date of Event
    July 29, 2022
    Report Date
    August 15, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024020030
    PMA / PMN Number
    K101977
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). PATIENT WEIGHT UNKNOWN / NOT PROVIDED. PMA/510K: K101880 .

    Description of Event or Problem · 0

    IT WAS REPORTED IMPLANT SITE BECAME INFECTED AND IMPLANT LOSE STABILITY, TOOTH 30. PER INDICATED: SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, INFLAMMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295243 IMP,TSV,4.7,8,MTX,MG DENTAL IMPLANT DZE ZIMMER DENTAL TSVTWB8 1247031 00889024020030

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Required Intervention