BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DENTAL IMPLANT

    MDR report key: 9384250 · Received November 27, 2019

    Report

    Report Number
    0002023141-2019-01206
    Event Type
    Malfunction
    Date Received
    November 27, 2019
    Report Date
    January 30, 2020
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION: IT HAS BEEN REPORTED THAT THE IMPLANT WAS NOT REMOVED AS REPORTED EARLIER, BUT IN FACT REMAINS IMPLANTED AT THIS POINT.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS ARE BEING REPORTED: H6: METHOD CODE WAS UPDATED TO 4112. H6: RESULTS CODE WAS UPDATED TO 3252. H6: CONCLUSIONS CODE WAS UPDATED TO 4307. PREVIOUSLY 0002023141-2019-01206 AND 0002023141-2019-01206-1 HAS BEEN SUBMITTED. THE REPORTED DEVICE WAS NOT RETURNED FOR EVALUATION. THE REPORTED CONDITION OF A FRACTURED IMPLANT WAS CONFIRMED BASED ON X-RAY ANALYSIS OF A X RAY PROVIDED BY CUSTOMER. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE AND EVENT. DHR AND COMPLAINT HISTORY REVIEWS COULD NOT BE PERFORMED SINCE THE LOT NUMBER ASSOCIATED TO THE UNKNOWN ITEM WAS NOT PROVIDED. A DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. H3 OTHER TEXT: DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 0

    IT IS REPORTED THAT THE UNKNOWN IMPLANT WAS FRACTURED BUT IS NOT REMOVED. IT REMAINS IMPLANTED.

    Description of Event or Problem · 0

    NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNKNOWN IMPLANT FRACTURED AND WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1175711 DENTAL IMPLANT DZE ZIMMER DENTAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention