BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ANKYLOS CX ABUTMENT

    MDR report key: 21345530 · Received February 10, 2025

    Report

    Report Number
    3013111692-2025-03566
    Event Type
    Injury
    Date Received
    February 10, 2025
    Date of Event
    November 25, 2024
    Report Date
    March 24, 2025
    Manufacturer
    DENTSPLY IMPLANTS MANUFACTURING GMBH
    Product Code
    NHA
    UDI-DI
    07392532206122
    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. 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

    ADDING ADDITIONAL INFORMATION THE INVESTIGATION OF THE RETURNED PRODUCT SHOWED, THAT THE IMPLANT WAS NOT FRACTURED, IT WAS REMOVED BECAUSE THE ABUTMENT HAD FRACTURED AND THE FRAGMENT WAS STUCK IN THE IMPLANT. THIS IS A FOLLOW UP REPORT FOR THIS ADDITIONAL INFORMATION. ADDING CONCOMITANT MEDICAL PRODUCTS - ANK C/X IMPL B9.5/D4.5/L9.5, REF 31010428, LOT B180002190. THIS IS A FOLLOW UP REPORT FOR THIS ADDITIONAL INFORMATION. ADDITIONAL FDA CODING BEING ADDED AFTER INVESTIGATION OF DEVICE. ADDING HEALTH EFFECT - IMPACT CODE: 4627. THIS IS A FOLLOW UP REPORT TO ADD THIS ADDITIONAL CODE. ADDITIONAL FDA CODING BEING ADDED AFTER INVESTIGATION OF DEVICE. ADDING ADDITIONAL TYPE OF INVESTIGATION CODE 10. THIS IS A FOLLOW UP REPORT TO ADD THIS ADDITIONAL CODE. DEVICE RECEIVED FOR THIS EVENT IS BEING CORRECTED FROM ANK C/X IMPL B9.5/D4.5/L9.5 CATALOG # 17-0553 TO UNKNOWN ANKYLOS CX ABUTMENT CATALOG # UNK ANKYLOS CX ABUTMENT. THIS IS A FOLLOW UP REPORT FOR THIS CORRECTED INFORMATION. CORRECTING LOT # FROM B180002190 TO UNK. THIS IS A FOLLOW UP REPORT FOR THIS CORRECTED INFORMATION. REMOVING UDI # 07392532206122. THIS IS A FOLLOW UP REPORT FOR THIS CORRECTED INFORMATION.

    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
    958875 UNKNOWN ANKYLOS CX ABUTMENT ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS NHA DENTSPLY IMPLANTS MANUFACTURING GMBH UNK 07392532206122

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention ANK C/X IMPL B9.5/D4.5/L9.5, REF (B)(4), LOT B18