MAUDE Adverse Event Report: THOMMEN MEDICAL AG CONTACT RC INICELL, PF 6.0, E 5.0, L12.5; DENTAL IMPLANT

Model Number	4.23.255
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/10/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Periodontal disease, implant didn't achieve osseointegration, immediate implantation, bone resorption, infection, mobility, smoker, implant loss due to immediate loading.

• Brand Name: CONTACT RC INICELL, PF 6.0, E 5.0, L12.5
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): THOMMEN MEDICAL AG; neckarsulmstrasse 28; grenchen 2540 ; CH 2540
• MDR Report Key: 8954636
• Report Number: 3003184527-2019-01027
• Device Sequence Number: 11415386
• Product Code: DZE
• UDI-Device Identifier: 07640156470901
• UDI-Public: 7640156470901
• Combination Product (Y/N): N
• PMA/510(K) Number: K090154
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 08/06/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/21/2012
• Device Model Number: 4.23.255
• Device Lot Number: 8783
• 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: 08/06/2019
• Initial Report FDA Received Date: 09/03/2019
• 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: 46 YR