MAUDE Adverse Event Report: THOMMEN MEDICAL AG ELEMENT RC INICELL, PF 6.0, E 6.0, L9.5; DENTAL IMPLANT

Model Number	4.23.153
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	10/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Implant didn't achieve osseointegration.

• Brand Name: ELEMENT RC INICELL, PF 6.0, E 6.0, 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: 18382792
• Report Number: 3003184527-2023-02412
• Device Sequence Number: 20785271
• Product Code: DZE
• UDI-Device Identifier: 07640156470758
• UDI-Public: 07640156470758
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 12/15/2023

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: 05/28/2024
• Device Model Number: 4.23.153
• Device Lot Number: 20204
• 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: Not provided
• Initial Report FDA Received Date: 12/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/28/2019
• 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: 67 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White