BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TAPERED SP 4.8MM 10M M OCTAGON

    MDR report key: 10727567 · Received October 23, 2020

    Report

    Report Number
    0002023141-2020-01762
    Event Type
    Malfunction
    Date Received
    October 23, 2020
    Date of Event
    September 17, 2020
    Report Date
    January 25, 2021
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K082639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ONE IMPL TAPERED SP 4.8MM 10M M OCTAGON (SPWB10) WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED SIGNS OF WEAR FROM USE ABOUT THE IMPLANT THREADS. NO PRE-EXISTING CONDITIONS WERE NOTED ON THE PER. THE REPORTED PRODUCT WAS LOCATED ON TOOTH # 20 (UNIVERSAL) AND REMOVED THE SAME DAY. THE REPORTED EVENT COULD BE RECREATED, AS FUNCTIONAL TESTING NOTES THE IMPLANT AND MOUNT COULD NOT BE DISENGAGED. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 2019061434. IT WAS CONFIRMED THAT ALL OPERATIONS AND INSPECTIONS WERE EXECUTED AS PER APPLICABLE PROCEDURE. NO DEVIATIONS OR NON-CONFORMANCES, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT WAS NOTED AS PART OF THE DHR. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (2019061434) FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. NOVEMBER POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT (STUCK COMPONENTS) OR PRODUCT (SPWB10). THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION HAS OCCURRED AND THE REPORTED EVENT WAS CONFIRMED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL PMA/510(K) NUMBER: K011245, K002188. DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IMPLANT FIXTURE MOUNT (SPWB10) COULD NOT DISENGAGE FROM THE IMPLANT BODY. IMPLANT WAS REMOVED AND PROCEDURE WAS COMPLETED USING ANOTHER IMPLANT. TOOTH LOCATION 20.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1195795 IMPL TAPERED SP 4.8MM 10M M OCTAGON DENTAL IMPLANT DZE ZIMMER DENTAL 2019061434

    Patients

    Seq Age Sex Outcome Treatment
    1