TPLC - Total Product Life Cycle

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Device	posterior metal/polymer spinal system, fusion
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
GLOBUS MEDICAL INC.
	SE - WITH LIMITATIONS	1
MEDTRONIC SOFAMOR DANEK USA, INC.
	SUBSTANTIALLY EQUIVALENT	2
MEDTRONIC SOFAMOR DANEK, USA INC.
	SUBSTANTIALLY EQUIVALENT	1
PARADIGM SPINE LLC
	SE - WITH LIMITATIONS	1
PARADIGM SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	1
ZIMMER SPINE, INC
	SUBSTANTIALLY EQUIVALENT	2
ZIMMER SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	60	60
Insufficient Information	58	58
Loose or Intermittent Connection	33	33
Adverse Event Without Identified Device or Use Problem	25	34
Fracture	22	23
Device Slipped	17	17
Appropriate Term/Code Not Available	11	11
Malposition of Device	7	7
Device Operates Differently Than Expected	7	7
Migration or Expulsion of Device	6	6
Patient Device Interaction Problem	5	6
Cut In Material	4	4
Loosening of Implant Not Related to Bone-Ingrowth	3	3
Difficult to Insert	3	3
Fitting Problem	2	2
Device-Device Incompatibility	2	2
Mechanical Jam	2	2
Mechanical Problem	2	2
Device Inoperable	2	2
Nonstandard Device	2	2
Difficult to Remove	2	2
Material Fragmentation	2	2
No Apparent Adverse Event	2	2
Partial Blockage	2	2
Noise, Audible	1	1
Detachment Of Device Component	1	1
Human-Device Interface Problem	1	1
Migration	1	1
Detachment of Device or Device Component	1	1
Sticking	1	1
Product Quality Problem	1	1
Device Handling Problem	1	1
Material Deformation	1	1
Misassembled	1	1
Bent	1	1
Mechanics Altered	1	1
Device Damaged by Another Device	1	1
Failure to Align	1	1
Component Missing	1	1
Use of Device Problem	1	1
Material Too Rigid or Stiff	1	1
Microbial Contamination of Device	1	1
Positioning Problem	1	1
Material Integrity Problem	1	1
Unintended Movement	1	1
Collapse	1	1
Torn Material	1	1
Crack	1	1
Entrapment of Device	1	1
Separation Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Information	56	56
No Code Available	54	54
Pain	38	38
No Known Impact Or Consequence To Patient	32	32
Failure of Implant	30	32
Unspecified Infection	18	18
Injury	15	15
Insufficient Information	15	22
No Clinical Signs, Symptoms or Conditions	13	21
Complaint, Ill-Defined	5	5
Hemothorax	5	5
Occlusion	4	4
Bone Fracture(s)	4	4
Spinal Column Injury	4	4
Collapse	4	4
Reaction	3	3
Fall	3	3
Ambulation Difficulties	2	2
Fluid Discharge	2	2
Discomfort	2	2
Device Embedded In Tissue or Plaque	1	1
Nervous System Injury	1	1
Spinal Cord Injury	1	1
No Consequences Or Impact To Patient	1	1
Therapeutic Effects, Unexpected	1	1
Stenosis	1	1
Abscess	1	1
Dyspnea	1	1
Weakness	1	1
Paralysis	1	1
Fever	1	1
Paresthesia	1	2
Post Operative Wound Infection	1	1
Device Overstimulation of Tissue	1	1
Neurological Deficit/Dysfunction	1	1
Perforation	1	1
Muscle Weakness	1	1
Hematoma	1	1
Ventricular Tachycardia	1	1
Necrosis	1	1
Halo	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1