MAUDE Adverse Event Report: THOMMEN MEDICAL AG ELEMENT IMPL., PF 4.5, E 4.2, L 9.5; DENTAL IMPLANT

Model Number 4.13.941

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 09/19/2020

Event Type  Injury  

Event Description

Implant fracture, implant achieved osseointegration, primary stability was achieved, implant was completely covered with bone, no thread tap used, bleeding.Given the type of fracture i think it was a structural defect of the implant.On (b)(6) 2020 the four-monthly check the patient is presented with a suitable crown and fractured implant as shown in the photo, implant removed when the instrumentation arrived.

• Brand Name: ELEMENT IMPL., PF 4.5, E 4.2, L 9.5
• 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: 11306915
• MDR Text Key: 231124459
• Report Number: 3003184527-2021-00263
• Device Sequence Number: 1
• Product Code: DZE
• UDI-Device Identifier: 07640156471373
• UDI-Public: 7640156471373
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 11/27/2020

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: 01/12/2020
• Device Model Number: 4.13.941
• Device Lot Number: 11658
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/27/2020
• Initial Date FDA Received: 02/10/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/12/2015
• 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: 60 YR