BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    ANKYLOS PLUS IMPLANT

    MDR report key: 10347262 · Received July 30, 2020

    Report

    Report Number
    9612468-2020-00061
    Event Type
    Malfunction
    Date Received
    July 30, 2020
    Report Date
    August 10, 2021
    Manufacturer
    DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB)
    Product Code
    DZE
    PMA / PMN Number
    K041509
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UPON FURTHER DISCUSSION WITH FDA, THE EVENTS INITIALLY REPORTED IN THIS SUMMARY REPORT ARE NOT CONSIDERED MALFUNCTION EVENTS, AND ARE SERIOUS INJURY EVENTS. THEREFORE, INDIVIDUAL REPORTS HAVE BEEN SUBMITTED FOR THE EVENTS PREVIOUSLY SUMMARIZED IN THIS REPORT. THIS SUMMARY REPORT NOW REFLECTS ZERO EVENTS AND CAN BE DISREGARDED/DELETED/REMOVED.

    Additional Manufacturer Narrative · 1

    THIS REPORT SUMMARIZES 75 MALFUNCTION EVENTS. 56 EVENTS WERE DUE TO LOSS OF OSSEOINTEGRATION (DEVICE PROBLEM CODE: 2408). 17 EVENTS INVOLVED FRACTURE OF THE DEVICE OR A COMPONENT (DEVICE PROBLEM CODE: 1260), WHICH WAS A MOUNT COMPONENT (DEVICE PROBLEM CODE: 887). 3 EVENTS INVOLVED A CRACK OF THE DEVICE (DEVICE PROBLEM CODE: 1135). 1 EVENT WAS DUE TO THE DEVICE FAILING TO OSSEOINTEGRATE (DEVICE PROBLEM CODE: 1863). IN 31 EVENTS, THERE WAS NO DEVICE PROBLEM FOUND DURING EVALUATION (EVALUATION RESULTS CODE: 213). IN 15 EVENTS, A FRACTURE OF A DEVICE OR DEVICE COMPONENT WAS FOUND DURING EVALUATION (EVALUATION RESULTS CODE: 3252). IN THESE SAME EVENTS, A STRESS PROBLEM WAS IDENTIFIED DURING EVALUATION (EVALUATION RESULTS CODE: 3243). IN 29 EVENTS, NO RESULT WAS AVAILABLE BECAUSE NO EVALUATION COULD BE PERFORMED (EVALUATION RESULTS CODE: 3221). IN 75 EVENTS, THESE ARE KNOWN INHERENT RISKS OF THE PROCEDURE. IN 13 EVENTS, THE DEVICE FAILURE WAS FOUND TO BE RELATED TO THE PATIENT'S CONDITION.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES <NOE> 75 </NOE> MALFUNCTION EVENTS. THIS REPORT SUMMARIZES 75 MALFUNCTION EVENTS IN 2Q 2020 WHERE PATIENTS' EXPERIENCED ENDOSSEOUS DENTAL IMPLANT FAILURE. OF THESE EVENTS THERE WERE: 9 EVENTS WHERE INFECTION OCCURRED. 10 EVENTS WHERE PATIENTS' EXPERIENCED OSTEOLYSIS. 29 EVENTS WHERE INFLAMMATION OCCURRED. 16 EVENTS WHERE EROSION OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    807152 ANKYLOS PLUS IMPLANT IMPLANT, ENDOSSEOUS, ROOT-FORM DZE DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB)

    Patients

    Seq Age Sex Outcome Treatment
    1