BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP TM 4.1MM MTX FULL, 11.5MM

    MDR report key: 10104771 · Received June 1, 2020

    Report

    Report Number
    0002023141-2020-00869
    Event Type
    Injury
    Date Received
    June 1, 2020
    Date of Event
    May 14, 2020
    Report Date
    August 14, 2020
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024018945
    PMA / PMN Number
    K132258
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT: (B)(4). THE FOLLOWING SECTION HAS BEEN UPDATED: UDI IS UNKNOWN.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). WEIGHT UNKNOWN / NOT PROVIDED. PMA/510K: K113753, K112160.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANT FRACTURED. IMPLANT FRACTURE OCCURRED AT MIDSECTION OF TRABECULAR BONE IMPLANT. PATIENT EXPERIENCED PAIN. PROCEDURE WAS NOT COMPLETED USING ANOTHER DEVICE AND IT WAS NOT INDICATED THAT THE PATIENT WILL RETURN FOR ADDITIONAL APPOINTMENTS. TOOTH LOCATION 19.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568226 IMP TM 4.1MM MTX FULL, 11.5MM DENTAL IMPLANT DZE ZIMMER DENTAL TMT4B11 62178508 00889024018945

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention