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
MEDTRONIC SOFAMOR DANEK USA, INC.
	SUBSTANTIALLY EQUIVALENT	2
MEDTRONIC SOFAMOR DANEK, USA INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fracture	13	14
Adverse Event Without Identified Device or Use Problem	12	21
Insufficient Information	6	6
Patient Device Interaction Problem	5	6
Break	4	4
Loosening of Implant Not Related to Bone-Ingrowth	3	3
Appropriate Term/Code Not Available	3	3
Difficult to Insert	2	2
Fitting Problem	1	1
Separation Problem	1	1
Mechanical Problem	1	1
Unintended Movement	1	1
Material Integrity Problem	1	1
Device Damaged by Another Device	1	1
Misassembled	1	1
Material Deformation	1	1
Device Handling Problem	1	1
Product Quality Problem	1	1
Detachment of Device or Device Component	1	1
No Apparent Adverse Event	1	1
Migration	1	1
Human-Device Interface Problem	1	1
Mechanical Jam	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Insufficient Information	15	22
Failure of Implant	14	16
No Clinical Signs, Symptoms or Conditions	13	21
No Information	12	12
No Code Available	3	3
Unspecified Infection	2	2
Spinal Column Injury	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Muscle Weakness	1	1
Paresthesia	1	2
Discomfort	1	1
Pain	1	1
No Consequences Or Impact To Patient	1	1
Nervous System Injury	1	1