TPLC - Total Product Life Cycle

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Device	growing rod system- magnetic actuation
Regulation Description	Thoracolumbosacral pedicle screw system.
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
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Defective Device	237	237
Mechanical Jam	142	142
Corroded	130	130
Mechanical Problem	128	128
Break	128	128
Failure to Advance	95	95
Migration or Expulsion of Device	59	59
Adverse Event Without Identified Device or Use Problem	54	54
Fracture	53	53
Migration	43	43
Physical Resistance/Sticking	39	39
Naturally Worn	35	35
Scratched Material	28	28
Degraded	28	28
Structural Problem	27	27
Detachment of Device or Device Component	25	25
Defective Component	25	25
Insufficient Information	17	17
No Apparent Adverse Event	16	16
Unstable	15	15
Appropriate Term/Code Not Available	10	10
Retraction Problem	7	7
Material Protrusion/Extrusion	5	5
Material Erosion	5	5
Material Twisted/Bent	3	3
Material Discolored	3	3
Noise, Audible	3	3
Therapeutic or Diagnostic Output Failure	2	2
Loosening of Implant Not Related to Bone-Ingrowth	2	2
Dent in Material	2	2
Fluid/Blood Leak	1	1
Material Fragmentation	1	1
Material Deformation	1	1
Electromagnetic Interference	1	1
Crack	1	1
Component Missing	1	1
Unintended Movement	1	1
Unexpected Therapeutic Results	1	1
Particulates	1	1
Activation, Positioning or Separation Problem	1	1
Malposition of Device	1	1
Separation Problem	1	1
Failure to Seal	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Failure of Implant	732	732
No Clinical Signs, Symptoms or Conditions	74	74
No Known Impact Or Consequence To Patient	51	51
Insufficient Information	48	48
Metal Related Pathology	28	28
Unspecified Infection	26	26
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	25	25
Pain	14	14
Skin Discoloration	5	5
Purulent Discharge	4	4
Fever	4	4
Inflammation	4	4
Wound Dehiscence	3	3
Drug Resistant Bacterial Infection	3	3
Spinal Cord Injury	2	2
Deformity/ Disfigurement	2	2
No Code Available	2	2
No Information	2	2
Decreased Appetite	2	2
Implant Pain	2	2
Localized Skin Lesion	2	2
Joint Laxity	2	2
Hemorrhage/Bleeding	2	2
Bacterial Infection	2	2
Ossification	2	2
Burning Sensation	2	2
Necrosis	2	2
Infiltration into Tissue	1	1
Headache	1	1
Foreign Body Reaction	1	1
Fall	1	1
Burn(s)	1	1
No Consequences Or Impact To Patient	1	1
Cerebral Ventriculomeglia	1	1
Swelling	1	1
Blood Loss	1	1
Fluid Discharge	1	1
Patient Problem/Medical Problem	1	1
Skin Erosion	1	1
Sepsis	1	1
Seizures	1	1
Local Reaction	1	1
Post Operative Wound Infection	1	1
Low Oxygen Saturation	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Globus Medical, Inc.	II	Apr-23-2025
2	NuVasive Inc	II	May-05-2020
3	NuVasive Specialized Orthopedics, Inc.	II	Dec-14-2022
4	NuVasive Specialized Orthopedics, Inc.	II	Jan-26-2022