BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOM IMPLANT 3.4 X 8.0

    MDR report key: 11985412 · Received June 11, 2021

    Report

    Report Number
    0008020776-2021-02429
    Event Type
    Injury
    Date Received
    June 11, 2021
    Date of Event
    May 8, 2021
    Report Date
    June 11, 2021
    Manufacturer
    ANTHOGYR
    Product Code
    DZE
    UDI-DI
    03663394000055
    PMA / PMN Number
    K101913
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 LOSS OF AN ENDOSSEOUS DENTAL IMPLANT AFTER SUCCESSFUL OSSEOINTEGRATION AND RESTORATION IS A KNOWN INHERENT RISK OF THE PROCEDURE. IMPLANTS MAY HAVE TO BE REMOVED IN CASE ONE OR MORE OF THE IMPLANT SUCCESS CRITERIA ARE NOT MET. IMPLANT SUCCESS CRITERIA ACCORDING TO BUSER ET AL. (1991) ARE: ABSENCE OF PERSISTENT SUBJECTIVE COMPLAINTS SUCH AS PAIN, FOREIGN BODY SENSATION AND /OR DYSESTHESIA. ABSENCE OF A RECURRENT PERI-IMPLANT INFECTION WITH SUPPURATION. ABSENCE OF IMPLANT MOBILITY. ABSENCE OF A CONTINUOUS RADIOLUCENCY AROUND THE IMPLANT. THE MANUFACTURER'S TREND ANALYSIS CONFIRMS THAT THE REPORTED FAILURE RATE ASSOCIATED WITH ITS DENTAL IMPLANTS IS BELOW THE EXPECTED FAILURE RATE FOR THIS TREATMENT AS PUBLISHED IN THE SCIENTIFIC LITERATURE.

    Description of Event or Problem · 1

    THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2017 IN FDI 45. ON (B)(6) 2021 , LOSS OF OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. THERE WERE NO PATIENT OPERATIVE OR POST-OPERATIVE COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    883919 AXIOM IMPLANT 3.4 X 8.0 ENDOSSEOUS DENTAL IMPLANT DZE ANTHOGYR OP34080 16-137735 03663394000055

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention