MAUDE Adverse Event Report: THOMMEN MEDICAL AG ELEMENT RC INICELL, PF 3.5, E 3.5, L8.0; DENTAL IMPLANT

Model Number 4.23.112

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 04/03/2019

Event Type  Injury  

Event Description

Implant fracture, loss of osseointegration.

• Brand Name: ELEMENT RC INICELL, PF 3.5, E 3.5, L8.0
• 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: 9075121
• MDR Text Key: 158776661
• Report Number: 3003184527-2019-01197
• Device Sequence Number: 1
• Product Code: DZE
• Combination Product (y/n): N
• Reporter Country Code: ES
• 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: 08/20/2019

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: 4.23.112
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/20/2019
• Initial Date FDA Received: 09/17/2019
• Was Device Evaluated by Manufacturer?: No
• 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: 82 YR