BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP,TSV,MCOL MG,4.7MM,10M

    MDR report key: 11120299 · Received January 5, 2021

    Report

    Report Number
    0002023141-2021-00027
    Event Type
    Malfunction
    Date Received
    January 5, 2021
    Report Date
    January 5, 2021
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019775
    PMA / PMN Number
    K111889
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). AGE AND DATE OF BIRTH UNKNOWN / NOT PROVIDED, PATIENT SEX UNKNOWN / NOT PROVIDED, WEIGHT UNKNOWN / NOT PROVIDED, DATE OF EVENT UNKNOWN / NOT PROVIDED, K101880.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS NO IMPLANT IN THE PACKAGING WHEN THEY OPENED IT. THE CONTAINER WAS EMPTY, THE PROCEDURE WAS COMPLETED USING ANOTHER IMPLANT. IMPLANT LOCATION NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13808 IMP,TSV,MCOL MG,4.7MM,10M DENTAL IMPLANT DZE ZIMMER DENTAL TSVMWB10 63024023 00889024019775

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention