MAUDE Adverse Event Report: Thommen Medical AG ELEMENT Impl. RC INICELL® 3.0, L 11.0; Dental Implant

Model Number	4.23.104
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	01/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Primary stability not achieved.

• Brand Name: ELEMENT Impl. RC INICELL® 3.0, L 11.0
• Common Device Name: Dental Implant
• Manufacturer (Section D): Thommen Medical AG; neckarsulmstrasse 28; grenchen 2540 ; CH 2540
• Manufacturer (Section G): Thommen Medical AG; neckarsulmstrasse 28; grenchen 2540 ; CH 2540
• Manufacturer Contact: astrid weber ; neckarsulmstrasse 28; grenchen 2540 ; CH 2540
• MDR Report Key: 50911024
• Report Number: 3003184527-2026-01684
• Device Sequence Number: 12206610
• Product Code: DZE
• UDI-Device Identifier: 07640156478549
• UDI-Public: 07640156478549
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K171795
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 09/11/2026

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/11/2026
• Device Model Number: 4.23.104
• Device Lot Number: 24534
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/11/2021
• 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: 68 YR
• Patient Sex: Female
• Patient Race: White