BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ANKYLOS ABUTMENT

    MDR report key: 16701833 · Received April 7, 2023

    Report

    Report Number
    3013111692-2023-39020
    Event Type
    Injury
    Date Received
    April 7, 2023
    Date of Event
    January 11, 2023
    Report Date
    June 9, 2023
    Manufacturer
    DENTSPLY IMPLANTS MANUFACTURING GMBH
    Product Code
    DZE
    PMA / PMN Number
    K140347
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. THE DEVICE WAS NOT EVALUATED BECAUSE THE ISSUE IS A KNOWN INHERENT RISK OF THE DEVICE. WE WILL CONTINUE TO TRACK AND MONITOR THE TREND.

    Additional Manufacturer Narrative · 0

    THIS CASE WAS ORIGINALLY REPORTED AS IMPLANT LOSS. LATER WE RECEIVED INFORMATION, THAT THIS WAS A MISTAKE BY THE CUSTOMER. THE CASE IS A FRACTURE OF AN ABUTMENT AND THE IMPLANT IS STILL LOADABLE. THIS MEANS, THAT THE CASE IS NON SERIOUS AND NOT REPORTABLE. THIS ADDITIONAL INFORMATION CHANGES THE STATUS FROM SERIOUS TO NON-SERIOUS, THIS EVENT IS NOW A NON-REPORTABLE EVENT. COMPLAINT IS NON-SERIOUS. NO REGULATORY REPORT FOR THIS COMPLAINT DEVICE RECEIVED FOR THIS EVENT IS BEING CORRECTED FROM ANK C/X IMPL A9.5/D3.5/L9.5 CATALOG # 17-0543 TO UNKNOWN ANKYLOS ABUTMENT CATALOG # UNKNOWN ANKYLOS ABUTMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1730601 UNKNOWN ANKYLOS ABUTMENT IMPLANT, ENDOSSEOUS, ROOT-FORM DZE DENTSPLY IMPLANTS MANUFACTURING GMBH B130000213

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention