MAUDE Adverse Event Report: BICON, LLC INTEGRA-TI; DENTAL IMPLANT

Catalog Number	260-145-306
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	08/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the account, there was poor bone integration for tooth #14.

• Brand Name: INTEGRA-TI
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BICON, LLC; 501 arborway; boston MA 02130
• Manufacturer (Section G): BICON, LLC; 501 arborway; boston MA 02130
• Manufacturer Contact: richard wu ; 501 arborway; boston, MA 02130 ; 6175244443
• MDR Report Key: 19287756
• Report Number: 1223843-2024-00004
• Device Sequence Number: 12959758
• Product Code: DZE
• UDI-Device Identifier: 00813110020932
• UDI-Public: (01)00813110020932(17)251031(10)161600920A
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K994037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 05/10/2024

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: 01/31/2025
• Device Catalogue Number: 260-145-306
• Device Lot Number: 161600920A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2024
• Initial Report FDA Received Date: 05/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/28/2020
• 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: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male