Osstell SmartPeg Type 101Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 09010522002131), received between May 15, 2025 and May 15, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Output Problem” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2025Output Problem; Output Problem

  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 MEASUREMENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22025608 ↗