MAUDE Adverse Event Report: THOMMEN MEDICAL AG ELEMENT IMPL., PF 4.5, E Ø 4.2, L 11.0; DENTAL IMPLANT

Model Number 4.13.911

Device Problem Break (1069)

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

Event Date 04/08/2022

Event Type  Injury  

Event Description

Implant fracture, implant achieved osseointegration, primary stability was achieved, implant was completely covered with bone, no thread tap used, bruxism.

• Brand Name: ELEMENT IMPL., PF 4.5, E Ø 4.2, L 11.0
• 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: 18343169
• MDR Text Key: 330659659
• Report Number: 3003184527-2023-02330
• Device Sequence Number: 1
• Product Code: DZE
• UDI-Device Identifier: 07640156471489
• UDI-Public: 07640156471489
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K072649
• 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: 10/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2017
• Device Model Number: 4.13.911
• Device Lot Number: 2495
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/27/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/30/2012
• 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: 45 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White