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

Model Number	260-340-258
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Tooth Fracture (2428)
Date of Event	09/18/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The implant was placed (b)(6) 2013 in type iv bone, which is the least dense bone type.The implant was uncovered on (b)(6) 2013.The type of bone being type iv means that integration of the bone to the implant would take longer than in dense bone.Uncovering after only two months is more likely to fail than if integrated for four to eight months.There were no x-rays between (b)(6) 2014 and (b)(6) 2017 of that tooth area so it is unknown if the bone had resorbed and made the implant mobile.The breakage pattern is consistent with stress at the point of the abutment ending in the implant which indicates movement.The event may have been avoided with longer integration times.
Event or Problem Description
The doctor reported a patient with a fractured implant.The implant was placed on (b)(6) 2013.The fractured part of the implant and the abutment was provided.

• Brand Name: INTEGRA-CP
• Common Device Name: IMPLANT
• Manufacturer (Section D): BICON, LLC; 501 arborway; boston MA 02130
• MDR Report Key: 6888167
• Report Number: 1223843-2017-00004
• Device Sequence Number: 13612413
• Product Code: DZE
• UDI-Device Identifier: 00813110022615
• UDI-Public: (01)00813110022615(10)006630313B(17)180430
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K092035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 09/22/2017

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: Dentist
• Device Expiration Date: 04/30/2018
• Device Model Number: 260-340-258
• Device Catalogue Number: 260-340-258
• Device Lot Number: 006630313B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/18/2017
• Initial Report FDA Received Date: 09/22/2017
• 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: 73 YR