MAUDE Adverse Event Report: THOMMEN MEDICAL AG ELEMENT IMPL., PF Ø 5.0, E Ø 5.0, L 11.0; DENTAL IMPLANT

Model Number	4.13.912
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/17/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Thread tap used, primary stability was achieved, implant didn't achieve osseointegration, mobility.

• Brand Name: ELEMENT IMPL., PF Ø 5.0, E Ø 5.0, L 11.0
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): THOMMEN MEDICAL AG; neckarsulmstrasse 28; grenchen 2540 ; CH 2540
• MDR Report Key: 8622938
• Report Number: 3003184527-2019-00620
• Device Sequence Number: 2169117
• Product Code: DZE
• UDI-Device Identifier: 07640156471472
• UDI-Public: 7640156471472
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K072649
• 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
• Report Date (Section B): 04/24/2019

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: 08/25/2024
• Device Model Number: 4.13.912
• Device Lot Number: 16398
• 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: 04/24/2019
• Initial Report FDA Received Date: 05/20/2019
• 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: 50 YR