BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,6.0,8,MTX,MG

    MDR report key: 12804512 · Received November 12, 2021

    Report

    Report Number
    0002023141-2021-03253
    Event Type
    Injury
    Date Received
    November 12, 2021
    Date of Event
    July 10, 2021
    Report Date
    November 12, 2021
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019911
    PMA / PMN Number
    K101977
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). PATIENT WEIGHT NOT PROVIDED. ADDITIONAL 510(K) NUMBER IS K101880. SUMMARY INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT WAS UNABLE TO BE PLACED DUE TO A LACK OF PRIMARY STABILITY. PATIENT WILL RETURN FOR IMPLANT PLACEMENT IN THE FUTURE. TOOTH #3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1705714 IMP,TSV,6.0,8,MTX,MG DENTAL IMPLANT DZE ZIMMER DENTAL TSVT6B8 1243901 00889024019911

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Required Intervention