BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DZE

    MDR report key: 10653715 · Received October 8, 2020

    Report

    Report Number
    0002023141-2020-01599
    Event Type
    Injury
    Date Received
    October 8, 2020
    Date of Event
    December 19, 2019
    Report Date
    January 20, 2021
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING SECTIONS HAVE BEEN UPDATED: G7: CHECKED "FOLLOW-UP."

    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). A SUMMARY INVESTIGATION HAS BEEN COMPLETED FOR BONE LOSS EVENTS RECOGNIZING THAT A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED DUE TO A WIDE RANGE OF EXTERNAL FACTORS (NON-DESIGN OR MANUFACTURING RELATED), INCLUDING MEDICAL CONDITIONS (E.G., DIABETES, POOR BONE QUALITY, ETC.) / PATIENT HABITS (E.G., SMOKING) AND SURGICAL TECHNIQUE. PREVIOUSLY COMPLETED INVESTIGATIONS FOR BONE LOSS HAVE NOT IDENTIFIED ANY SIGNALS INDICATING POTENTIAL NON-CONFORMANCE AFFECTING THE MANUFACTURING AND STERILIZATION PROCESSES. FURTHERMORE, THE PROBABILITY OF MANUFACTURING OR DESIGN DEFECTS THAT MIGHT LEAD TO BONE LOSS AND ESCAPING THE AVAILABLE DETECTIONS HAS BEEN ASSESSED AND FOUND REMOTE AND ALMOST NONEXISTENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED WHICH INDICATES THAT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AN ADDITIONAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANT IN SITE #13 DEVELOPED BONE LOSS AND WAS REMOVED. THE PATIENT WILL HAVE TO RETURN FOR AN ADDITIONAL APPOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1117847 DZE DZE ZIMMER DENTAL

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention