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	05/16/2023
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, complication in site preparation (extremely hard bone, no more primary stability after repeated preparation), immediate implantation, pain, mobility.(b)(4) are the same patient.

• 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: 17189784
• Report Number: 3003184527-2023-01222
• Device Sequence Number: 5754584
• Product Code: DZE
• UDI-Device Identifier: 07640156470758
• UDI-Public: 07640156470758
• Combination Product (Y/N): N
• Initial Reporter Country: DE
• 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): 06/16/2023

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 Model Number: 4.23.153
• Device Lot Number: 26781
• 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: 06/16/2023
• Initial Report FDA Received Date: 06/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/17/2022
• 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: 52 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White