MAUDE Adverse Event Report: THOMMEN MEDICAL AG CONTACT IMPL., PF 3.5, E Ø 2.7, L 11.0; DENTAL IMPLANT

Model Number 4.13.220

Device Problem Break (1069)

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

Event Date 04/02/2021

Event Type  Injury  

Event Description

Implant fracture, implant achieved osseointegration, implant was completely covered with bone, pain.

• Brand Name: CONTACT IMPL., PF 3.5, E Ø 2.7, 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: 12801722
• MDR Text Key: 280683972
• Report Number: 3003184527-2021-01622
• Device Sequence Number: 1
• Product Code: DZE
• UDI-Device Identifier: 07640156471700
• UDI-Public: 07640156471700
• 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: 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
• Device Operator: Health Professional
• Device Model Number: 4.13.220
• Device Lot Number: 19664
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/07/2021
• Initial Date FDA Received: 11/12/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/11/2019
• 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: 74 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White