BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ANKYLOS ABUTMENT

    MDR report key: 15370191 · Received September 7, 2022

    Report

    Report Number
    3013111692-2022-18076
    Event Type
    Injury
    Date Received
    September 7, 2022
    Date of Event
    July 27, 2022
    Report Date
    September 29, 2022
    Manufacturer
    DENTSPLY IMPLANTS MANUFACTURING GMBH
    Product Code
    DZE
    PMA / PMN Number
    K140347
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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

    FDA CODING WAS MISSED IN THE INITIAL REPORT. ADDING ADDITIONAL COMPONENT CODE 887. THIS IS A FOLLOW UP REPORT TO ADD THIS ADDITIONAL CODE. FDA CODING WAS MISSED IN THE INITIAL REPORT. ADDING ADDITIONAL INVESTIGATION TYPE CODE 10. THIS IS A FOLLOW UP REPORT TO ADD THIS ADDITIONAL CODE. THIS IS TO CORRECT AND REMOVE THE CODES THAT WERE INITIALLY REPORTED - REMOVING CODES FOR: INVESTIGATION FINDINGS CODE - 3243. THE PHYSICAL INVESTIGATION OF THE RETURNED ITEMS REVEALED THAT NO FRACTURE HAD OCCURRED. 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. REMOVING CONCOMITANT MEDICAL PRODUCTS - ANKYLOS ABUTMENT UNKNOWN.

    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
    1146407 UNKNOWN ANKYLOS ABUTMENT IMPLANT, ENDOSSEOUS, ROOT-FORM DZE DENTSPLY IMPLANTS MANUFACTURING GMBH 0020051925

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention ANKYLOS ABUTMENT UNKNOWN.