MAUDE Adverse Event Report: THOMMEN MEDICAL AG ELEMENT MC INICELL, PF 6.0, E 6.0, L8.0; DENTAL IMPLANT

Model Number	4.23.552
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/04/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Implant didn't achieve osseointegration, pain, mobility.

• Brand Name: ELEMENT MC INICELL, PF 6.0, E 6.0, L8.0
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): THOMMEN MEDICAL AG; neckarsulmstrasse 28; grenchen 2540 ; CH 2540
• MDR Report Key: 10604714
• Report Number: 3003184527-2020-01594
• Device Sequence Number: 2941196
• Product Code: DZE
• UDI-Device Identifier: 07640156470031
• UDI-Public: 7640156470031
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K090154
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 09/28/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: 4.23.552
• Device Lot Number: 12201
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2020
• Initial Report FDA Received Date: 09/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 42 YR