BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,1-PC,ANG,3.0X13MM

    MDR report key: 9180381 · Received October 11, 2019

    Report

    Report Number
    0002023141-2019-00883
    Event Type
    Injury
    Date Received
    October 11, 2019
    Date of Event
    March 25, 2019
    Report Date
    December 19, 2019
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K071235
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS ARE BEING REPORTED: DATE OF THIS REPORT WAS UPDATED. EXPIRATION DATE WAS ADDED. DATE RECEIVED BY MANUFACTURER WAS UPDATED. TYPE OF REPORT WAS UPDATED. TYPE OF FOLLOW UP WAS UPDATED. DEVICE EVALUATED BY MANUFACTURER WAS UPDATED. DEVICE MANUFACTURER DATE WAS ADDED. METHOD CODE WAS UPDATED TO 3331 AND 4109. RESULTS CODE WAS UPDATED TO 312. CONCLUSIONS CODE WAS UPDATED TO 4310. NARRATIVE/DATA WAS UPDATED. THE REPORTED DEVICE WAS RECEIVED FOR EVALUATION. THE REPORTED CONDITION OF PAIN WAS NOT CONFIRMED. VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED MINOR WEAR AND DEBRIS ABOUT THE IMPLANT THREADS FROM USAGE. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE AND EVENT. A DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED FOR THE REPORTED DEVICE LOT. IT WAS CONFIRMED THAT ALL OPERATIONS AND INSPECTIONS WERE EXECUTED AS PER APPLICABLE PROCEDURE. NO DEVIATIONS OR NON-CONFORMANCE, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT WAS NOTED AS PART OF THE DHR. A COMPLAINT HISTORY REVIEW WAS COMPLETED FOR THE REPORTED DEVICE LOT FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. 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.

    Description of Event or Problem · 0

    NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL 510(K) NUMBER IS K052997.

    Description of Event or Problem · 1

    DOCTOR REPORTED THAT HE REMOVED THE IMPLANT ZOP30A13 DUE TO PAIN. TOOTH SITE # 8.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    975285 IMP,1-PC,ANG,3.0X13MM DENTAL IMPLANT DZE ZIMMER DENTAL 61979071

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention