BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DENTAL IMPLANT

    MDR report key: 17274194 · Received July 6, 2023

    Report

    Report Number
    0002023141-2023-01806
    Event Type
    Injury
    Date Received
    July 6, 2023
    Date of Event
    December 29, 2020
    Report Date
    August 22, 2023
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). 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.

    Additional Manufacturer Narrative · 0

    BASED ON UPDATED CUSTOMER INFORMATION RECEIVED AND REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED THAT MFR REPORT NUMBER 0002023141-2023-01806 WAS REPORTED IN ERROR. PLEASE DISREGARD THIS SUBMISSION. NO FURTHER REPORTS WILL BE SUBMITTED FOR THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO INFECTION. A 13MM POCKET WAS NOTED, THE SITE WAS CLEANED AND LASER BACTERIAL REDUCTION (LBR) DONE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO INFECTION. A 13MM POCKET WAS NOTED, THE SITE WAS CLEANED AND LASER BACTERIAL REDUCTION (LBR) DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614020 DENTAL IMPLANT DZE ZIMMER DENTAL

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention