TPLC - Total Product Life Cycle

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Device	pedicle screw spinal system, adolescent idiopathic scoliosis
Definition	Intended to stabilize the thoracolumbar spine as an adjunct to fusion using allograft and/or autograft to treat adolescent idiopathic scoliosis.
Product Code	OSH
Regulation Number	888.3070
Device Class	2

Premarket Reviews
Manufacturer	Decision
ASTURA MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
BIOMET SPINE (AKA EBI, LLC)
	SUBSTANTIALLY EQUIVALENT	1
DEPUY SPINE, A JOHNSON & JOHNSON COMPANY
	SUBSTANTIALLY EQUIVALENT	1
GLOBUS MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	1
IMPLANET S.A.
	SUBSTANTIALLY EQUIVALENT	1
K2M, INC.
	SE - WITH LIMITATIONS	3
	SUBSTANTIALLY EQUIVALENT	3
MEDICREA INTERNATIONAL
	SE - WITH LIMITATIONS	1
	SUBSTANTIALLY EQUIVALENT	2
MEDTRONIC SOFAMOR DANEK
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC SOFAMOR DANEK USA
	SUBSTANTIALLY EQUIVALENT	1
ORTHOPEDIATRICS, CORP.
	SUBSTANTIALLY EQUIVALENT	1
	SE - WITH LIMITATIONS	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fracture	21	21
Break	19	19
Migration	15	15
Adverse Event Without Identified Device or Use Problem	8	8
Material Twisted/Bent	7	7
Material Integrity Problem	6	6
Detachment Of Device Component	4	4
Device Issue	4	4
Device Slipped	3	3
Detachment of Device or Device Component	2	2
Insufficient Information	2	2
Naturally Worn	2	2
Material Separation	2	2
Device Dislodged or Dislocated	2	2
No Apparent Adverse Event	1	1
Therapeutic or Diagnostic Output Failure	1	1
Use of Device Problem	1	1
Device Operates Differently Than Expected	1	1
Loosening of Implant Not Related to Bone-Ingrowth	1	1
Mechanical Jam	1	1
Unintended Movement	1	1
Mechanical Problem	1	1
Positioning Problem	1	1
Disconnection	1	1
Malposition of Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	16	16
No Clinical Signs, Symptoms or Conditions	13	13
Congenital Defect/Deformity	11	11
Pain	11	11
No Information	10	10
Failure of Implant	9	9
Insufficient Information	7	7
Injury	6	6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Implant Pain	4	4
No Code Available	3	3
No Consequences Or Impact To Patient	3	3
Unspecified Infection	3	3
Nerve Damage	2	2
Osteolysis	2	2
Joint Laxity	2	2
Reaction	1	1
Post Operative Wound Infection	1	1
Device Embedded In Tissue or Plaque	1	1
Anxiety	1	1
Depression	1	1
Non-union Bone Fracture	1	1
Neurological Deficit/Dysfunction	1	1
Spinal Column Injury	1	1
Emotional Changes	1	1
Bone Fracture(s)	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	OrthoPediatrics Corp	II	Feb-14-2018