MAUDE Adverse Event Report: THOMMEN MEDICAL AG ELEMENT MC INICELL, PF 4.5, E 4.2, L14.0; 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	02/15/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
No primary stability, implant didn't achieve osseointegration, implant wasn't completely covered by bone, inadequate bone quality/quantity, asymptomatic.

• Brand Name: ELEMENT MC INICELL, PF 4.5, E 4.2, L14.0
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): THOMMEN MEDICAL AG; neckarsulmstrasse 28; grenchen 2540 ; CH 2540
• MDR Report Key: 8423839
• Report Number: 3003184527-2019-00290
• Device Sequence Number: 2227798
• Product Code: DZE
• UDI-Device Identifier: 07640156470093
• UDI-Public: 7640156470093
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K090154
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 03/15/2019

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: 01/05/2022
• Device Model Number: 4.23.536
• Device Lot Number: 15109
• 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: 03/15/2019
• Initial Report FDA Received Date: 03/15/2019
• 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: 62 YR