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

Model Number	260-340-251
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/10/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The implant and abutment are still in function.
Event or Problem Description
According to dr.(b)(6), he has an implant with a fractured floor.He said the abutment has come out multiple times and at the last visit, he discovered the fractured well.He gave the history of the implant: "implant placed (b)(6) 2016 restored on (b)(6) 2016 abutment and crown came out on (b)(6) 2017 again (b)(6) 2018 again (b)(6) 2018 again (b)(6) 2018 again (b)(6) 2018 it was then i took a new impression and had a whole new abutment and crown made thinking that something was just not milled correctly in the abutment.Again the new abutment and crown came out on (b)(6) 2018 and finally being at my wits end i did some further investigation and found that the floor of the well had a hole in it." he cemented the abutment at the last visit because he wasn't sure what to do.

• Brand Name: INTEGRA-CP
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BICON, LLC; 501 arborway; boston MA 02130
• MDR Report Key: 8101483
• Report Number: 1223843-2018-00004
• Device Sequence Number: 1345850
• Product Code: DZE
• UDI-Device Identifier: 00813110022585
• UDI-Public: (01)00813110022585(10)047270315B(17)200430
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K092035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 11/26/2018

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: 04/30/2020
• Device Model Number: 260-340-251
• Device Catalogue Number: 260-340-251
• Device Lot Number: 047270315B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/01/2018
• Initial Report FDA Received Date: 11/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR