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

Model Number	4.23.516
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/21/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Primary stability achieved, no osseointegration.Immediate implantation, pain, instability.

• Brand Name: ELEMENT MC INICELL, PF 3,5, E 3,5, L 14,0
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): THOMMEN MEDICAL AG; neckarsulmstrasse 28; grenchen, 2540 ; SZ 2540
• MDR Report Key: 7347560
• Report Number: 3003184527-2018-00230
• Device Sequence Number: 84274
• Product Code: DZE
• UDI-Device Identifier: 07640156470260
• UDI-Public: 7640156470260
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K093615
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 03/01/2018

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: Dentist
• Device Expiration Date: 08/19/2020
• Device Model Number: 4.23.516
• Device Lot Number: 14677
• 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: 03/16/2018
• Initial Report FDA Received Date: 03/17/2018
• 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: 66 YR