MAUDE Adverse Event Report: KEYSTONE DENTAL TRI NEX; TRNX IMP D43 X 10.5MM LNG

Model Number	IA-LH-43-10
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/10/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Loss of osseointegration.

• Brand Name: TRI NEX
• Common Device Name: TRNX IMP D43 X 10.5MM LNG
• Manufacturer (Section D): KEYSTONE DENTAL; 154 middlesex turnpike; burlington MA 01803
• MDR Report Key: 9397600
• Report Number: 3005990499-2019-10085
• Device Sequence Number: 14141118
• Product Code: DZE
• UDI-Device Identifier: D768IALH43100
• UDI-Public: +D768IALH43100/$$321043028800/
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 11/27/2019

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: IA-LH-43-10
• Device Catalogue Number: IA-LH-43-10
• Device Lot Number: 28800
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2019
• Initial Report FDA Received Date: 12/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1