MAUDE Adverse Event Report: THOMMEN MEDICAL AG ELEMENT RC INICELL, PF 3.5, E 3.5, L12.5; DENTAL IMPLANT

Model Number 4.23.115

Device Problem Break (1069)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/16/2022

Event Type  Injury  

Event Description

Implant fracture.Implant achieved osseointegration, primary stability was achieved, implant was completely covered with bone, no thread tap used, chemotherapy around time of implant placement, mobility.

• Brand Name: ELEMENT RC INICELL, PF 3.5, E 3.5, L12.5
• Type of Device: 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: 15665509
• MDR Text Key: 302330757
• Report Number: 3003184527-2022-01865
• Device Sequence Number: 1
• Product Code: DZE
• UDI-Device Identifier: 07640156471281
• UDI-Public: 07640156471281
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K090154
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 08/31/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2023
• Device Model Number: 4.23.115
• Device Lot Number: 17491
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/31/2022
• Initial Date FDA Received: 10/25/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/14/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White