TPLC - Total Product Life Cycle

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Device	growing rod system- magnetic actuation
Definition	Stabilization or correction of spinal deformities without the use of fusion, using non-invasive methods to adjust the spinal rod.
Product Code	PGN
Regulation Number	888.3070
Device Class	2

Premarket Reviews
Manufacturer	Decision
ELLIPSE TECHNOLOGIES INC.
	SUBSTANTIALLY EQUIVALENT	1
ELLIPSE TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	2
ELLIPSE TECHNOLOGIES, INCORPORATED
	SUBSTANTIALLY EQUIVALENT	1
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
	SUBSTANTIALLY EQUIVALENT	3
NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED
	SUBSTANTIALLY EQUIVALENT	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Defective Device	240	240
Break	166	166
Mechanical Jam	142	142
Mechanical Problem	133	133
Corroded	130	130
Failure to Advance	92	92
Migration or Expulsion of Device	59	59
Adverse Event Without Identified Device or Use Problem	54	54
Fracture	52	52
Migration	43	43
Physical Resistance/Sticking	39	39
Naturally Worn	35	35
Degraded	28	28
Scratched Material	28	28
Structural Problem	27	27
Defective Component	26	26
Device Operates Differently Than Expected	26	26
Detachment of Device or Device Component	25	25
Insufficient Information	21	21
Appropriate Term/Code Not Available	17	17
No Apparent Adverse Event	16	16
Unstable	15	15
Material Separation	15	15
Retraction Problem	9	9
Device Inoperable	6	6
Mechanics Altered	5	5
Material Erosion	5	5
Material Protrusion/Extrusion	5	5
Noise, Audible	3	3
Material Discolored	3	3
Material Twisted/Bent	3	3
Therapeutic or Diagnostic Output Failure	3	3
Positioning Failure	2	2
Dent in Material	2	2
Detachment Of Device Component	2	2
Loosening of Implant Not Related to Bone-Ingrowth	2	2
Inadequacy of Device Shape and/or Size	1	1
Component Missing	1	1
Activation Failure	1	1
Unexpected Therapeutic Results	1	1
Electromagnetic Interference	1	1
Fluid/Blood Leak	1	1
Failure to Seal	1	1
Unintended Movement	1	1
Crack	1	1
Particulates	1	1
Device Operational Issue	1	1
Malposition of Device	1	1
Activation, Positioning or Separation Problem	1	1
Separation Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Failure of Implant	734	734
No Clinical Signs, Symptoms or Conditions	74	74
No Known Impact Or Consequence To Patient	73	73
No Code Available	51	51
Insufficient Information	45	45
No Information	32	32
Unspecified Infection	29	29
Metal Related Pathology	28	28
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	26	26
Pain	15	15
Skin Discoloration	7	7
No Consequences Or Impact To Patient	5	5
Inflammation	5	5
Purulent Discharge	4	4
Fever	4	4
Wound Dehiscence	3	3
Decreased Appetite	2	2
Spinal Cord Injury	2	2
Deformity/ Disfigurement	2	2
Hemorrhage/Bleeding	2	2
Bacterial Infection	2	2
Therapeutic Response, Decreased	2	2
Joint Laxity	2	2
Fall	2	2
Burning Sensation	2	2
Post Operative Wound Infection	2	2
Ossification	2	2
Localized Skin Lesion	2	2
Implant Pain	2	2
Necrosis	2	2
Drug Resistant Bacterial Infection	2	2
Patient Problem/Medical Problem	2	2
Foreign Body Reaction	1	1
Burn(s)	1	1
Skin Erosion	1	1
Swelling	1	1
Blood Loss	1	1
Cerebral Ventriculomeglia	1	1
Fluid Discharge	1	1
Local Reaction	1	1
Tissue Damage	1	1
Bone Fracture(s)	1	1
Sepsis	1	1
Seizures	1	1
Headache	1	1
Infiltration into Tissue	1	1
Low Oxygen Saturation	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	NuVasive Inc	II	May-05-2020
2	NuVasive Specialized Orthopedics, Inc.	II	Dec-14-2022
3	NuVasive Specialized Orthopedics, Inc.	II	Jan-26-2022