MAUDE Adverse Event Report: OSSTELL AB OSSTELL SMARTPEG TYPE 101, 102, 103, 104; Handpiece, direct drive, ac-powered

Model Number	TYPE 101, TYPE 102, TYPE 103, TYPE 104
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Notice sent to users with reinforcement of instructions for use.
Event or Problem Description
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.

• Brand Name: OSSTELL SMARTPEG TYPE 101, 102, 103, 104
• Common Device Name: Handpiece, direct drive, ac-powered
• Manufacturer (Section D): OSSTELL AB; stampgatan 14; goteborg, 41101 ; SW 41101
• MDR Report Key: 22025608
• Report Number: 3004070020-2025-00001
• Device Sequence Number: 9114692
• Product Code: EKX
• UDI-Device Identifier: 09010522002131
• UDI-Public: 09010522002131
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Dentist
• Remedial Action: Notification,Relabeling
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: TYPE 101, TYPE 102, TYPE 103, TYPE 104
• Device Catalogue Number: 100766, 100767, 100768, 100769
• Device Lot Number: 106736, 106841
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown