MAUDE Adverse Event Report: KEYSTONE DENTAL TRINEX; TRNX IMP D4.3 X 11.5MM LNG

Model Number	IA-LH-43-11.5
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Osteopenia/ Osteoporosis (2651)
Date of Event	12/07/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Failure to osseointegrate.

• Brand Name: TRINEX
• Common Device Name: TRNX IMP D4.3 X 11.5MM LNG
• Manufacturer (Section D): KEYSTONE DENTAL; 154 middlesex turnpike; burlington MA 01803
• MDR Report Key: 9601553
• Report Number: 3005990499-2020-10350
• Device Sequence Number: 2040946
• Product Code: DZE
• UDI-Device Identifier: D768IALH431150
• UDI-Public: +D768IALH431150/$$322113036738B
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 01/16/2020

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-43-11.5
• Device Catalogue Number: IA-LH-43-11.5
• Device Lot Number: 36738
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2020
• Initial Report FDA Received Date: 01/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR