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	178	178
Mechanical Jam	142	142
Corroded	130	130
Mechanical Problem	128	128
Break	112	112
Failure to Advance	95	96
Migration or Expulsion of Device	55	55
Adverse Event Without Identified Device or Use Problem	53	53
Fracture	50	50
Migration	42	42
Physical Resistance/Sticking	39	39
Naturally Worn	34	34
Degraded	28	28
Scratched Material	28	28
Structural Problem	27	27
Detachment of Device or Device Component	24	24
Defective Component	24	24
Insufficient Information	17	17
No Apparent Adverse Event	15	15
Unstable	15	15
Retraction Problem	7	7
Material Protrusion/Extrusion	5	5
Appropriate Term/Code Not Available	5	5
Material Erosion	5	5
Material Twisted/Bent	3	3
Noise, Audible	3	3
Material Discolored	3	3
Dent in Material	2	2
Loosening of Implant Not Related to Bone-Ingrowth	2	2
Failure to Seal	1	1
Malposition of Device	1	1
Activation, Positioning or Separation Problem	1	1
Unintended Movement	1	1
Particulates	1	1
Fluid/Blood Leak	1	1
Component Missing	1	1
Electromagnetic Interference	1	1
Therapeutic or Diagnostic Output Failure	1	1
Crack	1	1
Material Deformation	1	1
Material Fragmentation	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Failure of Implant	694	695
No Clinical Signs, Symptoms or Conditions	74	74
Insufficient Information	48	49
Metal Related Pathology	28	28
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	25	25
Unspecified Infection	25	25
Pain	14	14
Skin Discoloration	5	5
Fever	4	4
Inflammation	4	4
Purulent Discharge	4	4
Drug Resistant Bacterial Infection	3	3
Wound Dehiscence	3	3
Implant Pain	2	2
Bacterial Infection	2	2
Deformity/ Disfigurement	2	2
Decreased Appetite	2	2
Spinal Cord Injury	2	2
Joint Laxity	2	2
Burning Sensation	2	2
No Information	2	2
Localized Skin Lesion	2	2
Necrosis	2	2
Ossification	2	2
Hemorrhage/Bleeding	2	2
No Code Available	2	2
Cerebral Ventriculomeglia	1	1
Infiltration into Tissue	1	1
Fall	1	1
Burn(s)	1	1
Headache	1	1
Post Operative Wound Infection	1	1
Local Reaction	1	1
Foreign Body Reaction	1	1
Skin Erosion	1	1
Sepsis	1	1
Fluid Discharge	1	1
Seizures	1	1
No Known Impact Or Consequence To Patient	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