MAUDE Adverse Event Report: THOMMEN MEDICAL AG CONTACT RC INICELL, PF 4,5, E 3,5, L 14,0; DENTAL IMPLANT

Model Number	4.23.236
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/06/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Primary stability achieved, no osseointegration.Instability.

• Brand Name: CONTACT RC INICELL, PF 4,5, E 3,5, L 14,0
• 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: 7489287
• Report Number: 3003184527-2018-00432
• Device Sequence Number: 3699847
• Product Code: DZE
• UDI-Device Identifier: 07640156470994
• UDI-Public: 7640156470994
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 04/23/2018

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: 09/17/2020
• Device Model Number: 4.23.236
• Device Lot Number: 12810
• 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: 05/04/2018
• Supplement Date Received by Manufacturer: 05/04/2018
• Initial Report FDA Received Date: 05/05/2018
• Supplement Report FDA Received Date: 05/05/2018
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/17/2015
• 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: 37 YR
• Patient Sex: Female