MAUDE Adverse Event Report: CONTACT RC INICELL, PF 3.5, E 2.7, L12.5; DENTAL IMPLANT

Model Number	4.23.215
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	08/18/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Implant didn't achieve osseointegration, no thread tap used.

• Brand Name: CONTACT RC INICELL, PF 3.5, E 2.7, L12.5
• Common Device Name: DENTAL IMPLANT
• MDR Report Key: 12744005
• Report Number: 3003184527-2021-01552
• Device Sequence Number: 14572667
• Product Code: DZE
• UDI-Device Identifier: 07640156471083
• UDI-Public: 07640156471083
• Combination Product (Y/N): N
• Initial Reporter Country: DE
• PMA/510(K) Number: K090154
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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: 12/11/2023
• Device Model Number: 4.23.215
• Device Lot Number: 19124
• 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: 12/11/2018
• 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: 65 YR