BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP TM 4.1MM MTX FULL,10M

    MDR report key: 12106328 · Received July 2, 2021

    Report

    Report Number
    0002023141-2021-01686
    Event Type
    Injury
    Date Received
    July 2, 2021
    Report Date
    September 30, 2021
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024018938
    PMA / PMN Number
    K132258
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND NO RELATED DEVIATIONS OR NONCONFORMANCES WERE NOTED. ALSO, A COMPLAINT HISTORY SEARCH WAS PERFORMED USING OUR COMPLAINT HANDLING SYSTEM AND THERE WERE NO ADDITIONAL RELATED COMPLAINTS FOR THIS PRODUCT LOT.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). ADDITIONAL PMA/510(K) NUMBER ¿ K113753 / K112160.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANT COULD NOT BE PLACE DUE TO LACK OF PRIMARY STABILITY. A NEW IMPLANT WILL BE PLACED IN THE FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1002536 IMP TM 4.1MM MTX FULL,10M DENTAL IMPLANT DZE ZIMMER DENTAL TMT4B10 1235268 00889024018938

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention