MAUDE Adverse Event Report: ELEMENT MC INICELL, PF 6.0, E 6.0, L9.5; DENTAL IMPLANT

Model Number	4.23.553
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	09/08/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Loss of osseointegration, primary stability was achieved, implant was completely covered with bone, no thread tap used, mobility.

• Brand Name: ELEMENT MC INICELL, PF 6.0, E 6.0, L9.5
• Common Device Name: DENTAL IMPLANT
• MDR Report Key: 12743373
• Report Number: 3003184527-2021-01550
• Device Sequence Number: 11882030
• Product Code: DZE
• UDI-Device Identifier: 07640156470024
• UDI-Public: 07640156470024
• Combination Product (Y/N): N
• Initial Reporter Country: DE
• PMA/510(K) Number: K093615
• 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): 11/03/2021

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: 09/18/2018
• Device Model Number: 4.23.553
• Device Lot Number: 4497
• 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: 11/03/2021
• Initial Report FDA Received Date: 11/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/18/2013
• 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
• Patient Age: 58 YR