TPLC - Total Product Life Cycle

• Device: equipment, traction, powered
• Product Code: ITH
• Regulation Number: 890.5900
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ENRAF-NONIUS B.V.
	SUBSTANTIALLY EQUIVALENT	1
ERGO-FLEX TECHNOLOGIES, LLC
	SUBSTANTIALLY EQUIVALENT	1
EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HOLLYWOG, LLC
	SUBSTANTIALLY EQUIVALENT	1
INTEGRA LIFE SCIENCES
	SUBSTANTIALLY EQUIVALENT	1
INTEGRITY LIFE SCIENCES
	SUBSTANTIALLY EQUIVALENT	1
METTLER ELECTRONICS CORP.
	SUBSTANTIALLY EQUIVALENT	1
PIVOTAL HEALTH SOLUTIONS
	SUBSTANTIALLY EQUIVALENT	2
ZIMMER MEDIZINSYSTEME GMBH
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2014	5	5
2015	1	1
2016	2	2
2017	2	2
2019	5	5
2021	1	1
2023	1	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device Operates Differently Than Expected	4	4
Mechanical Problem	3	3
Unintended System Motion	2	2
Difficult to Remove	1	1
Retraction Problem	1	1
Sticking	1	1
Device Operational Issue	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Positioning Problem	1	1
Protective Measures Problem	1	1
Unintended Movement	1	1
Insufficient Information	1	1
Collapse	1	1
Use of Incorrect Control/Treatment Settings	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	7	7
No Patient Involvement	4	4
Pain	3	3
No Consequences Or Impact To Patient	2	2
Discomfort	1	1
Injury	1	1
Ambulation Difficulties	1	1
Insufficient Information	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Advanced Back Technologies, Inc.	II	Jun-05-2015
2	Mettler Electronics Corp	II	Jun-17-2011
3	Spinetronics, LLC	II	Apr-02-2012