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

Model Number	260-350-306
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	02/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Implant was inserted into site #5 under bicon protocol and using bicon reamers.The site was covered and sutured, waiting for 2nd stage uncovering and restoration.After a 5-month healing period, the patient presented for the 2nd stage, and the implant was completely non-integrated, floating in granulomatous tissue with mild purulence.The fixture was explanted, the site cleaned and bone graft with membrane placed.

• Brand Name: INTEGRA-CP
• 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: 16544665
• Report Number: 1223843-2023-00001
• Device Sequence Number: 12392318
• Product Code: DZE
• UDI-Device Identifier: 00813110022837
• UDI-Public: (01)00813110022837(17)270531(10)186320422B
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K062044
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 03/15/2023

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 Model Number: 260-350-306
• Device Catalogue Number: 260-350-306
• Device Lot Number: 186320422B
• 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: 03/14/2023
• Initial Report FDA Received Date: 03/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2022
• 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: 53 YR
• Patient Sex: Male