MAUDE Adverse Event Report: Thommen Medical AG ELEMENT RC INICELL, PF 4.5, E 4.2, L9.5; Dental Implant

Model Number	4.23.133
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	06/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Primary stability not achieved, implant wasn't completely covered with bone, no thread tap used, inadequate bone quality/quantity, preceding/simultaneous bone augmentation, mobility.

• Brand Name: ELEMENT RC INICELL, PF 4.5, E 4.2, L9.5
• 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: 50930938
• Report Number: 3003184527-2026-01717
• Device Sequence Number: 9688893
• Product Code: DZE
• UDI-Device Identifier: 07640156471199
• UDI-Public: 07640156471199
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K090154
• 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): 09/28/2026

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 Model Number: 4.23.133
• Device Lot Number: 40316
• 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: 09/28/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/27/2026
• 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: 59 YR
• Patient Sex: Male
• Patient Race: White