MAUDE Adverse Event Report: THOMMEN MEDICAL AG ELEMENT IMPLANT, PF 6,0, E 6,0, L 6,5; DENTAL IMPLANT

Model Number	4.13.908
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/24/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Sinus infection, increased sensitivity, mobility, loss of implant.

• Brand Name: ELEMENT IMPLANT, PF 6,0, E 6,0, L 6,5
• 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: 7506572
• Report Number: 3003184527-2018-00453
• Device Sequence Number: 9130916
• Product Code: DZE
• UDI-Device Identifier: 07640156470819
• UDI-Public: 7640156470819
• 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: 2012
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2017

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: Health Professional
• Device Expiration Date: 12/15/2014
• Device Model Number: 4.13.908
• Device Lot Number: 6599
• 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: 05/02/2018
• Supplement Date Received by Manufacturer: 05/02/2018
• Initial Report FDA Received Date: 05/11/2018
• Supplement Report FDA Received Date: 05/11/2018
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/18/2009
• 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: 51 YR
• Patient Sex: Male