MAUDE Adverse Event Report: THOMMEN MEDICAL AG ELEMENT IMPL., PF 4.5, E 4.2, L 12.5; DENTAL IMPLANT

Model Number	4.13.951
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	04/08/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Loss of osseointegration, implant achieved osseointegration, primary stability was achieved, implant was completely covered with bone, peri-implantitis, mobility - first crown was fractured in 2019 and got replaced.

• Brand Name: ELEMENT IMPL., PF 4.5, E 4.2, L 12.5
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): THOMMEN MEDICAL AG; neckarsulmstrasse 28; grenchen 2540 ; CH 2540
• MDR Report Key: 11776570
• Report Number: 3003184527-2021-00775
• Device Sequence Number: 4427748
• Product Code: DZE
• UDI-Device Identifier: 07640156471335
• UDI-Public: 07640156471335
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K072649
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 04/15/2021

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: 11/25/2013
• Device Model Number: 4.13.951
• Device Lot Number: 5205
• 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: 04/15/2021
• Initial Report FDA Received Date: 05/05/2021
• 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: 85 YR