MAUDE Adverse Event Report: ELEMENT LC INICELL, PF 4.0, E 4.0, L9.5; DENTAL IMPLANT

Model Number	4.23.723
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	09/20/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Loss of osseointegration, illness requiring steroids, psychological disorder, xerostomia, pain, swelling.Patient presented with implant #6 out.

• Brand Name: ELEMENT LC INICELL, PF 4.0, E 4.0, L9.5
• Common Device Name: DENTAL IMPLANT
• MDR Report Key: 12679235
• Report Number: 3003184527-2021-01480
• Device Sequence Number: 4012592
• Product Code: DZE
• UDI-Device Identifier: 07640156470208
• UDI-Public: 07640156470208
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K090154
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 10/22/2021

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: 06/28/2017
• Device Model Number: 4.23.723
• Device Lot Number: 2837
• 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: 10/22/2021
• Initial Report FDA Received Date: 10/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/28/2012
• 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