MAUDE Adverse Event Report: THOMMEN MEDICAL AG ELEMENT MC INICELL, PF 4.0, E 4.0, L8.0; DENTAL IMPLANT

Model Number	4.23.522
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	09/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Loss of osseointegration, primary stability was achieved, implant was completely covered with bone, no thread tap used, pain.

• Brand Name: ELEMENT MC INICELL, PF 4.0, E 4.0, L8.0
• 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: 24159689
• Report Number: 3003184527-2026-00269
• Device Sequence Number: 18399254
• Product Code: DZE
• UDI-Device Identifier: 07640156470239
• UDI-Public: 07640156470239
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K093615
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 01/23/2026

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: 4.23.522
• Device Lot Number: 28569
• 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: 01/23/2026
• Initial Report FDA Received Date: 01/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/18/2022
• 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: 62 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White