MAUDE Adverse Event Report: THOMMEN MEDICAL AG ELEMENT IMPL., PF Ø 4.0, E Ø 4.0, L 14.0; DENTAL IMPLANT

Model Number	4.13.944
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/12/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Loss of osseointegration - primary stability was achieved, implant achieved osseointegration, implant was completely covered by bone.Progressive bone loss.

• Brand Name: ELEMENT IMPL., PF Ø 4.0, E Ø 4.0, L 14.0
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): THOMMEN MEDICAL AG; neckarsulmstrasse 28; grenchen 2540 ; CH 2540
• MDR Report Key: 8281181
• Report Number: 3003184527-2019-00025
• Device Sequence Number: 2389509
• Product Code: DZE
• UDI-Device Identifier: 07640156471359
• UDI-Public: 7640156471359
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K072649
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 01/16/2019

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: 10/26/2012
• Device Model Number: 4.13.944
• Device Lot Number: 5102
• 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: 01/16/2019
• Initial Report FDA Received Date: 01/28/2019
• 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: 72 YR