MAUDE Adverse Event Report: THOMMEN MEDICAL AG ELEMENT LC INICELL, PF 4,0, E 4,0, L 11,0; DENTAL IMPLANT

Model Number	4.23.724
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/13/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
No primary stability achieved.

• Brand Name: ELEMENT LC INICELL, PF 4,0, E 4,0, L 11,0
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): THOMMEN MEDICAL AG; neckarsulmstrasse 28; grenchen, 2540 ; SZ 2540
• Manufacturer (Section G): THOMMEN MEDICAL AG; neckarsulmstrasse 28; grenchen, 2540 ; SZ 2540
• Manufacturer Contact: astrid weber ; neckarsulmstrasse 28; grenchen, 2540 ; SZ 2540
• MDR Report Key: 7468587
• Report Number: 3003184527-2018-00383
• Device Sequence Number: 11882858
• Product Code: DZE
• UDI-Device Identifier: 07640156470185
• UDI-Public: 7640156470185
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K093615
• 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,Followup
• Report Date (Section B): 04/19/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/25/2022
• Device Model Number: 4.23.724
• Device Lot Number: 16404
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2018
• Supplement Date Received by Manufacturer: 04/27/2018
• Initial Report FDA Received Date: 04/27/2018
• Supplement Report FDA Received Date: 04/27/2018
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/25/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 52 YR
• Patient Sex: Female