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	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	02/09/2021
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, no thread tap used, local infection / subacute chronic osteitis, infection, pain, swelling, mobility.

• 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: 12432790
• Report Number: 3003184527-2021-01260
• Device Sequence Number: 14428735
• Product Code: DZE
• UDI-Device Identifier: 07640156471335
• UDI-Public: 07640156471335
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K072649
• 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): 09/07/2021

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: 03/08/2026
• Device Model Number: 4.13.951
• Device Lot Number: 19654
• 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: 09/07/2021
• Initial Report FDA Received Date: 09/07/2021
• 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: 55 YR