MAUDE Adverse Event Report: THOMMEN MEDICAL AG ELEMENT RC INICELL, PF 4.5, E 4.2, L11.0; DENTAL IMPLANT

Model Number 4.23.134

Device Problem Break (1069)

Patient Problem Inadequate Osseointegration (2646)

Event Date 07/12/2022

Event Type  Injury  

Event Description

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

• Brand Name: ELEMENT RC INICELL, PF 4.5, E 4.2, L11.0
• 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: 15462094
• MDR Text Key: 300315655
• Report Number: 3003184527-2022-01689
• Device Sequence Number: 1
• Product Code: DZE
• UDI-Device Identifier: 07640156471182
• UDI-Public: 07640156471182
• Combination Product (y/n): N
• Reporter Country Code: DE
• 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: 09/05/2022

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: 12/31/2011
• Device Model Number: 4.23.134
• Device Lot Number: 8673
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/05/2022
• Initial Date FDA Received: 09/21/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/31/2010
• 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: 55 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White