BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP,TSV,MCOL MG,4.7MM,8MM

    MDR report key: 15163651 · Received August 4, 2022

    Report

    Report Number
    0002023141-2022-01958
    Event Type
    Malfunction
    Date Received
    August 4, 2022
    Date of Event
    June 30, 2022
    Report Date
    January 10, 2023
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019812
    PMA / PMN Number
    K111889
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). ADDITIONAL 510(K) NUMBER IS K101880.

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT MOUNT COULD NOT DISENGAGE FROM IMPLANT. PROCEDURE WAS COMPLETED USING ANOTHER IMPLANT.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2380968 IMP,TSV,MCOL MG,4.7MM,8MM DENTAL IMPLANT DZE ZIMMER DENTAL TSVMWB8 1248113 00889024019812

    Patients

    Seq Age Sex Outcome Treatment
    1 Male