MAUDE Adverse Event Report: KEYSTONE DENTAL INC TRINX; TRI-MAX IMP TRNX D8.0 X 9MM LNG

Model Number	TRI-MAX8-9
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/25/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Failure to osseointegrate.

• Brand Name: TRINX
• Common Device Name: TRI-MAX IMP TRNX D8.0 X 9MM LNG
• Manufacturer (Section D): KEYSTONE DENTAL INC; 154 middlesex turnpike; burlington MA 01803
• MDR Report Key: 9548995
• Report Number: 3005990499-2019-20243
• Device Sequence Number: 14068750
• Product Code: DZE
• UDI-Device Identifier: D768TRIMAX890
• UDI-Public: +D768TRIMAX890/$$3220430337571
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 12/16/2019

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: TRI-MAX8-9
• Device Catalogue Number: TRI-MAX8-9
• Device Lot Number: 33757
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2019
• Initial Report FDA Received Date: 01/03/2020
• 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: 63 YR