TPLC - Total Product Life Cycle

• Device: posterior metal/polymer spinal system, fusion
• Regulation Description: Pedicle screw spinal system.
• Definition: This device is a posterior spinal system that contains polymer and metal components. This spinal system is to be used with bone graft and is an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.
• Product Code: NQP
• Regulation Number: 888.3070
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
CENTERPULSE ORTHOPEDICS, INC.
	SUBSTANTIALLY EQUIVALENT - WITH LIMITATIONS	1
GLOBUS
	SUBSTANTIALLY EQUIVALENT - WITH LIMITATIONS	1
MEDTRONIC, INC.
	SUBSTANTIALLY EQUIVALENT	1
ZIMMER, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Implant breakage or physical damage	138
Break	66
Loose	26
Explanted	21
No Known Device Problem	9
Implant, removal of	6
Replace	6
Device remains implanted	5
Unknown (for use when the device problem is not known)	5
No Information	5
Malfunction	3
Implant, repositioning of	3
Fracture	3
Loose or intermittent connection	2
Migration of device or device component	2
Cable break	2
No code available	2
Defective item	1
Malposition of device	1
Device Issue	1
Internal fixation, revision of	1
Bent	1
Device, or device fragments remain in patient	1
Coagulation in device or device ingredient	1
Collapse	1
Connection error	1
Screw tapper, damaged	1
Disassembly	1
Displacement	1
Rupture due to capsulotomy	1
Sticking	1
Tip breakage	1
Screw head(s), incorrect	1
Fitting problem	1
Total Device Problems	321

Recalls
	2007	2008	2009	2010	2011	2012	2013
Class I	0	0	0	0	0	0	0
Class II	0	1	2	1	0	1	0
Class III	0	0	0	0	0	0	0

Recalls
Manufacturer		Recall Class	Date Posted
1	Medtronic Sofamor Danek USA Inc	II	Sep-11-2008
2	Synthes Spine	II	Feb-03-2009
3	Synthes USA (HQ), Inc.	II	Sep-01-2010
4	Zimmer Inc.	II	Nov-19-2009
5	Zimmer, Inc.	II	Nov-06-2012