MAUDE Adverse Event Report: THOMMEN MEDICAL AG CONTACT IMPL., PF Ø 5.0, E Ø 4.2, L 12.5; DENTAL IMPLANT

Model Number	4.13.232
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/25/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Loss of osseointegration - primary stability was achieved, implant surface was completely covered by bone, blood coagulation disorder, increased sensitivity, inflammation.

• Brand Name: CONTACT IMPL., PF Ø 5.0, E Ø 4.2, L 12.5
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): THOMMEN MEDICAL AG; neckarsulmstrasse 28; grenchen 2540 ; CH 2540
• MDR Report Key: 8435730
• Report Number: 3003184527-2019-00321
• Device Sequence Number: 277367
• Product Code: DZE
• UDI-Device Identifier: 07640156471632
• UDI-Public: 7640156471632
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K072649
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 03/12/2019

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: 10/31/2012
• Device Model Number: 4.13.232
• Device Lot Number: 5106
• 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: 03/12/2019
• Initial Report FDA Received Date: 03/20/2019
• 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: 72 YR