BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN ANKYLOS CX TOOL

    MDR report key: 24340957 · Received February 14, 2026

    Report

    Report Number
    3013111692-2026-06100
    Event Type
    Malfunction
    Date Received
    February 14, 2026
    Date of Event
    January 20, 2026
    Report Date
    March 31, 2026
    Manufacturer
    DENTSPLY IMPLANTS MANUFACTURING GMBH
    Product Code
    DZE
    UDI-DI
    07392532206122
    PMA / PMN Number
    K140347
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE HAS BEEN A PREVIOUS REPORT RECEIVED WHERE THIS MALFUNCTION RESULTED IN A SERIOUS INJURY. THEREFORE, IT MUST BE PRESUMED THAT RECURRENCE OF THIS MALFUNCTION COULD POSSIBLY CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE SUCH. AS SUCH, THIS EVENT IS REPORTABLE PER 21 CFR PART 803. 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

    DEVICE RECEIVED FOR THIS EVENT IS BEING CORRECTED FROM ANK C/X IMPL B9.5/D4.5/L9.5 CATALOG # 17-0553 LOT # 499871 UDI # 07392532206122 TO UNKNOWN ANKYLOS CX TOOL CATALOG # UNK ANKYLOS CX TOOL LOT # UNK UDI # NI. THIS IS A FOLLOW UP REPORT FOR THIS CORRECTED INFORMATION. THIS IS TO CORRECT AND REMOVE THE CODES THAT WERE INITIALLY REPORTED - REMOVING CODES FOR: MEDICAL DEVICE PROBLEM CODE - 2547. COMPONENT CODE - 887. THE CORRECT CODES FOR THIS COMPLAINT ARE: MEDICAL DEVICE PROBLEM CODE - 3190. COMPONENT CODE - 4755. THIS IS A FOLLOW UP REPORT TO CORRECT THIS CODE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN INSERTION ISSUE. THE IMPLANT WOULD NOT ENGAGE WITH THE INSERTION CARRIER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206928 UNKNOWN ANKYLOS CX TOOL IMPLANT, ENDOSSEOUS, ROOT-FORM DZE DENTSPLY IMPLANTS MANUFACTURING GMBH UNK 07392532206122

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown