BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NHA

    MDR report key: 22580551 · Received July 23, 2025

    Report

    Report Number
    3013111692-2025-19682
    Event Type
    Malfunction
    Date Received
    July 23, 2025
    Date of Event
    April 14, 2025
    Report Date
    August 22, 2025
    Manufacturer
    DENTSPLY IMPLANTS MANUFACTURING GMBH
    Product Code
    DZE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THEREFORE, BECAUSE A SERIOUS INJURY RESULTED, THIS EVENT IS REPORTABLE PER 21 CFR PART 803. SECTION H6 WAS DONE BASED ON THE INFORMATION PROVIDED BY THE INITIAL REPORTER AND OUR LONG-TIME EXPERIENCE IN THE INVESTIGATION OF SIMILAR COMPLAINTS. PRODUCT RETURN IS REQUESTED AND PRODUCT WILL BE EVALUATED AFTER RECEIPT. IN CASE ANY NEW OR ADDITIONAL INFORMATION WILL BE GAINED FROM THIS INVESTIGATION A FOLLOW-UP REPORT WILL BE SENT. TREND IS TRACKED AND MONITORED.

    Additional Manufacturer Narrative · 0

    WE RECEIVED ADDITIONAL INFORMATION THAT A SECOND RETRIEVAL ATTEMPT WAS SUCCESSFUL, AND THE IMPLANT IS NOW RESTORABLE, THEREFORE, THIS EVENT IS BEING CHANGED TO A MALFUNCTION REPORT AS IT DID NOT RESULT IN IMPLANT LOSS. B1 UPDATED TO PRODUCT PROBLEM. H1 UPDATED TO MALFUNCTION. NOT REPORTABLE. IN THIS CASE AN ABUTMENT FRACTURED AND AN ATTEMPT TO RETRIEVE THE ABUTMENT FAILED. THEREFORE, THE CASE WAS INITIALLY REPORTED AS A FAILED IMPLANT. THERE WAS RECEIVED INFORMATION, THAT A SECOND RETRIEVAL WAS MADE AND WAS SUCCESSFUL. THIS MEANS, THE IMPLANT IS RESTORABLE, AND THE CASE IS NOT REPORTABLE. D1 AND D4: BRAND NAME AND CATALOG UPDATED TO NHA.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT FRACTURE AND THE IMPLANT WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855112 NHA IMPLANT, ENDOSSEOUS, ROOT-FORM DZE DENTSPLY IMPLANTS MANUFACTURING GMBH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention