MAUDE Adverse Event Report: ARGON MEDICAL PRODUCTIONS & VERTRIEBSGESELLSCHAFT K3PRO DENTAL IMPLANTS; K3PRO R-LINE IMPLANT

Model Number	4,5 X 9 MM R-LINE
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	03/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient has lost an implant due to osseointegration failure.
Additional Manufacturer Narrative
The malfunction is not our non-osseointegrated dental implant itself, but rather insufficient integration with the surrounding bone.This is influenced by factors such as bone quality, stress and the patient's healing ability.

• Brand Name: K3PRO DENTAL IMPLANTS
• Common Device Name: K3PRO R-LINE IMPLANT
• Manufacturer (Section D): ARGON MEDICAL PRODUCTIONS & VERTRIEBSGESELLSCHAFT; franz kirsten strasse 1; bingen am rhein, rheinland pfalz DE-55 411; GM DE-55411
• Manufacturer (Section G): ARGON MEDICAL PRODUCTIONS & VERTRIEBSGESELLSCHAFT; franz kirsten strasse 1; bingen am rhein, rheinland pfalz DE-55 411; GM DE-55411
• Manufacturer Contact: marianne ebelmann ; franz kirsten strasse 1; bingen am rhein, rheinland pfalz DE-55-411 ; GM DE-55411
• MDR Report Key: 24740524
• Report Number: 3011575197-2026-23037
• Device Sequence Number: 12465147
• Product Code: NHA
• UDI-Device Identifier: EAGN45009K3PROR0
• UDI-Public: +EAGN45009K3PROR0
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K141159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 03/31/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 4,5 X 9 MM R-LINE
• Device Catalogue Number: 45009K3PRO R-LINE
• Device Lot Number: 630721
• 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: 03/06/2023
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2022
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 58 YR
• Patient Sex: Male