BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZTETIC DENTAL IMPLANT, 3.1MM DIAMETER, 2.9MMD PLATFORM, 10MM LENGTH

    MDR report key: 11058336 · Received December 22, 2020

    Report

    Report Number
    0002023141-2020-02375
    Event Type
    Injury
    Date Received
    December 22, 2020
    Date of Event
    November 2, 2020
    Report Date
    January 11, 2021
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024343870
    PMA / PMN Number
    K142082
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT # (B)(4). THIS REPORT IS BEING RELAYED TO CORRECT THE PREVIOUSLY REPORTED MFR- 0002023141 - 2020 - 02375 - 1. AFTER ADDITIONAL INFORMATION WAS RECEIVED ON JAN 06, 2021, IT WAS DETERMINED THAT THIS EVENT NO LONGER MEETS THE CRITERIA OF A REPORTABLE EVENT THAT IF IT WERE TO RECUR WOULD CAUSE OR CONTRIBUTED TO A DEATH AND / OR SERIOUS INJURY. AS A RESULT, THE PRIOR SUBMISSION (MFR- 0002023141 - 2020 - 02375 - 1) SUBMITTED ON DEC 22, 2020 IS NO LONGER CONSIDERED A REPORTABLE EVENT BY THE MANUFACTURER AND NO FURTHER REPORT WILL BE SUBMITTED FOR THIS EVENT. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B5: DESCRIBE EVENT OR PROBLEM.

    Description of Event or Problem · 0

    THE ASSOCIATED COMPLAINT (B)(4) IS BEING INVALIDATED DUE TO BEING A DUPLICATE OF COMPLAINT (B)(4). THEREFORE THIS RECORD IS BEING PHASED TO NOT A COMPLAINT.

    Additional Manufacturer Narrative · 1

    (B)(4). WEIGHT UNKNOWN / NOT PROVIDED. INFECTION: A SUMMARY INVESTIGATION HAS BEEN COMPLETED FOR INFECTION EVENTS IDENTIFYING THAT A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED DUE TO THE WIDE RANGE OF EXTERNAL (NON-DESIGN/ NON-MANUFACTURING RELATED) FACTORS POTENTIALLY IMPACTING THE STERILITY OF THE IMPLANT AND ITS ENVIRONMENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED WHICH INDICATES THAT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE INFECTION EVENT, AN ADDITIONAL REPORT WILL BE SUBMITTED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANT FAILED DUE TO AN INFECTION AND WAS REMOVED. PATIENT HAS PAST HISTORY OF OSTEOMYELITIS IN THE AREA AND BELIEVES THIS IS RELATED. MASSIVE OSSEOUS DEFECT AROUND ANTERIOR OF IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1520063 EZTETIC DENTAL IMPLANT, 3.1MM DIAMETER, 2.9MMD PLATFORM, 10MM LENGTH DENTAL IMPLANT DZE ZIMMER DENTAL CT3110 1238349 00889024343870

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention