BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSSTELL SMARTPEG TYPE 101, 102, 103, 104

    MDR report key: 22025608 · Received May 15, 2025

    Report

    Report Number
    3004070020-2025-00001
    Event Type
    Malfunction
    Date Received
    May 15, 2025
    Manufacturer
    OSSTELL AB
    Product Code
    EKX
    UDI-DI
    09010522002131
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NOTICE SENT TO USERS WITH REINFORCEMENT OF INSTRUCTIONS FOR USE.

    Description of Event or Problem · 0

    IT WAS REPORTED SMARTPEGS (TYPE 101, TYPE 102, TYPE 103 AND TYPE 104) HAVE A DIFFERENT BEHAVIOUR THAN OTHER SMARTPEG TYPES. OSSTELL SMARTPEGS ARE INTENDED TO BE USED AS AN ACCESSORY TO OSSTELL INSTRUMENTS FOR MEASURING IMPLANT STABILITY. THE MEASUREMENT RESULTS ARE PRESENTED USING THE ISQ SCALE WHERE A HIGHER VALUE INDICATES A HIGHER LEVEL OF STABILITY. THE FOUR TYPES OF SMARTPEGS (TYPE 101 - TYPE 104) RELATED TO THIS REPORT ARE INTENDED FOR USE ON IMPLANT LEVEL ON TWO SPECIFIC IMPLANT MODELS, AND ON ABUTMENT LEVEL ON TWO SPECIFIC ABUTMENT MODELS COMPATIBLE TO THOSE SPECIFIC IMPLANT MODELS. MEASUREMENT RESULTS ON ABUTMENT-LEVEL NORMALLY DIFFER SLIGHTLY FROM MEASUREMENT RESULTS ON IMPLANT-LEVEL. THE INSTRUCTIONS FOR USE THEREFORE INCLUDES THE RECOMMENDATION TO IDENTIFY THE ISQ DIFFERENCE TO THE MEASUREMENT PERFORMED AT IMPLANT LEVEL, BY TAKING A MEASUREMENT ON THE IMPLANT BEFORE THE ABUTMENT IS ATTACHED AND THEN A SECOND MEASUREMENT ON THE ABUTMENT. MOST COMMONLY THE MEASURED VALUE IS SLIGHTLY LOWER ON ABUTMENT LEVEL THAN ON IMPLANT LEVEL. BUT WITH THE SMARTPEG TYPES RELATED TO THIS REPORT, ABUTMENT-LEVEL MEASUREMENTS RESULT IN A POSITIVE OFFSET COMPARED TO IMPLANT-LEVEL MEASUREMENTS. IF NOT CORRECTLY USED WITH A REFERENCE MEASUREMENT ON IMPLANT LEVEL, THE MEASUREMENT ON ABUTMENT CAN INDICATE A FALSE HIGH IMPLANT STABILITY. THIS CAN INFLUENCE THE CLINICIAN TO TAKE THE WRONG DECISION AND LOAD THE IMPLANT TOO EARLY, IN THE EXTENSION POTENTIALLY RESULTING IN IMPLANT FAILURE FOR THE PATIENT. NO ADVERSE EVENT HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1754919 OSSTELL SMARTPEG TYPE 101, 102, 103, 104 Handpiece, direct drive, ac-powered EKX OSSTELL AB TYPE 101, TYPE 102, TYPE 103, TYPE 104 106736, 106841 09010522002131

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown