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	163	163
Mechanical Jam	142	142
Mechanical Problem	133	133
Corroded	130	130
Failure to Advance	75	75
Migration or Expulsion of Device	59	59
Adverse Event Without Identified Device or Use Problem	54	54
Fracture	51	51
Migration	43	43
Physical Resistance/Sticking	38	38
Naturally Worn	35	35
Scratched Material	28	28
Degraded	27	27
Structural Problem	27	27
Device Operates Differently Than Expected	26	26
Defective Component	26	26
Detachment of Device or Device Component	22	22
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 Protrusion/Extrusion	5	5
Material Twisted/Bent	3	3
Therapeutic or Diagnostic Output Failure	3	3
Noise, Audible	3	3
Material Erosion	3	3
Positioning Failure	2	2
Material Discolored	2	2
Detachment Of Device Component	2	2
Dent in Material	2	2
Loosening of Implant Not Related to Bone-Ingrowth	2	2
Separation Problem	1	1
Activation Failure	1	1
Unintended Movement	1	1
Positioning Problem	1	1
Component Missing	1	1
Metal Shedding Debris	1	1
Malposition of Device	1	1
Activation, Positioning or Separation Problem	1	1
Device Operational Issue	1	1
Device Dislodged or Dislocated	1	1
Material Deformation	1	1
Crack	1	1
Electromagnetic Interference	1	1
Fluid/Blood Leak	1	1
Material Fragmentation	1	1
Loose or Intermittent Connection	1	1
Inadequacy of Device Shape and/or Size	1	1
Unexpected Therapeutic Results	1	1
Particulates	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Failure of Implant	726	726
No Clinical Signs, Symptoms or Conditions	74	74
No Known Impact Or Consequence To Patient	73	73
No Code Available	51	51
Insufficient Information	33	33
No Information	32	32
Unspecified Infection	29	29
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	26	26
Metal Related Pathology	24	24
Pain	15	15
Skin Discoloration	7	7
Inflammation	5	5
No Consequences Or Impact To Patient	5	5
Purulent Discharge	4	4
Fever	4	4
Wound Dehiscence	3	3
Ossification	2	2
Bacterial Infection	2	2
Fall	2	2
Therapeutic Response, Decreased	2	2
Deformity/ Disfigurement	2	2
Spinal Cord Injury	2	2
Post Operative Wound Infection	2	2
Necrosis	2	2
Hemorrhage/Bleeding	2	2
Burning Sensation	2	2
Localized Skin Lesion	2	2
Drug Resistant Bacterial Infection	2	2
Implant Pain	2	2
Decreased Appetite	2	2
Joint Laxity	2	2
Patient Problem/Medical Problem	2	2
Skin Erosion	1	1
Swelling	1	1
Tissue Damage	1	1
Cerebral Ventriculomeglia	1	1
Low Oxygen Saturation	1	1
Blood Loss	1	1
Fluid Discharge	1	1
Infiltration into Tissue	1	1
Local Reaction	1	1
Seizures	1	1
Sepsis	1	1
Burn(s)	1	1
Foreign Body Reaction	1	1
Bone Fracture(s)	1	1
Headache	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