MAUDE Adverse Event Report: THOMMEN MEDICAL AG ELEMENT MC INICELL; DENTAL IMPLANT

Model Number 4.23.515

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Code Available (3191)

Event Date 12/21/2017

Event Type  Injury  

Event Description

Poor hygiene around implant, implant mobile, heavy smoker, hardly ever removed denture for cleaning.

• Brand Name: ELEMENT MC INICELL
• Type of Device: DENTAL IMPLANT
• Manufacturer (Section D): THOMMEN MEDICAL AG; neckarsulmstrasse 28; 2540 grenchen, sz ; SZ
• MDR Report Key: 7247200
• MDR Text Key: 99204061
• Report Number: 3003708589-2018-00010
• Device Sequence Number: 1
• Product Code: DZE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 02/05/2018,01/08/2018

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: Dentist
• Device Expiration Date: 10/12/2020
• Device Model Number: 4.23.515
• Device Catalogue Number: 4.23.515
• Device Lot Number: 12900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/05/2018
• Distributor Facility Aware Date: 01/24/2018
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 01/29/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other