MAUDE Adverse Event Report: THOMMEN MEDICAL AG ELEMENT MC INICELL, PF 4,5, E 4,2, L 14,0; DENTAL IMPLANT

Model Number	4.23.536
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/12/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Failure to osseointegrate, inadequate bone, pain, bone resorption, infection (same patient as (b)(6).

• Brand Name: ELEMENT MC INICELL, PF 4,5, E 4,2, L 14,0
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): THOMMEN MEDICAL AG; neckarsulmstrasse 28; grenchen, 2540 ; SZ 2540
• MDR Report Key: 7273367
• Report Number: 3003184527-2018-00085
• Device Sequence Number: 16438282
• Product Code: DZE
• UDI-Device Identifier: 07640156470093
• UDI-Public: 7640156470093
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 12/21/2017

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: 03/28/2022
• Device Model Number: 4.23.536
• Device Lot Number: 11901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2018
• Initial Report FDA Received Date: 02/15/2018
• 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: 31 YR