BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOM IMPLANT PX 4.6 X 10.0

    MDR report key: 12034269 · Received June 21, 2021

    Report

    Report Number
    0008020776-2021-02824
    Event Type
    Injury
    Date Received
    June 21, 2021
    Date of Event
    June 13, 2020
    Report Date
    June 21, 2021
    Manufacturer
    ANTHOGYR
    Product Code
    DZE
    UDI-DI
    03663394000352
    PMA / PMN Number
    K161177
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE BATCH NUMBER COULD BE VERIFIED. OUR MANUFACTURING Q-SYSTEM ASSURES, THAT PRODUCTION AND PROCESS CONTROLS ARE IN PLACE TO ENSURE THAT BATCHES CONFIRM TO THE APPLICABLE SPECIFICATIONS BEFORE THEY ARE DISTRIBUTED.  THE REMOVAL OF A DENTAL IMPLANT DURING SURGERY WITHOUT THE REPLACEMENT OF ANOTHER DENTAL IMPLANT IS A KNOWN INHERENT RISK OF THE PROCEDURE DUE TO EITHER LACK OF PRIMARY STABILITY OF THE IMPLANT (PATIENOR PROCEDURE RELATED). IT MAY ALSO INCLUDE THE REMOVAL OF AN IMPLANT AFTER OSSEOINTEGRATION DUE TO EITHER THE CLINICIAN'S OR PATIENT¿S DECISION. THE MANUFACTURER¿S TREND ANALYSIS CONFIRMS THAT USUALLY PROCEDURAL ERRORS AND/OR PATIENT'S CONDITION CONTRIBUTE TO THE EVENT.

    Description of Event or Problem · 1

    THE CLINICIAN REPORTS THAT THE DAY THE IMPLANT WAS PLACED IN FDI 36, FAILURE OCCURRED UPON INSERTION. DETAILS OF SURGERY: PRIMARY STABILITY NOT ACHIEVED. PATIENT PRESENTED WITH BONE TYPE III. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. THERE WERE NO REPORTED PATIENT INJURIES OR COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    927368 AXIOM IMPLANT PX 4.6 X 10.0 ENDOSSEOUS DENTAL IMPLANT DZE ANTHOGYR PX46100 18-297016 03663394000352

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention