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

Model Number	4.23.722
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	06/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Implant didn't achieve osseointegration, primary stability was achieved, implant was completely covered with bone, smoker, peri-implantitis, infection, pain, swelling, abscess, inflammation ((b)(6) are same patient).

• Brand Name: ELEMENT LC 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
• MDR Report Key: 12427959
• Report Number: 3003184527-2021-01220
• Device Sequence Number: 17465959
• Product Code: DZE
• UDI-Device Identifier: 07640156470222
• UDI-Public: 07640156470222
• Combination Product (Y/N): N
• Initial Reporter Country: HR
• PMA/510(K) Number: K090154
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 08/31/2021

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: 09/10/2025
• Device Model Number: 4.23.722
• Device Lot Number: 22693
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2021
• Initial Report FDA Received Date: 09/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR