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, INCORPORATED
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Mechanical Jam	138	138
Corroded	127	127
Break	95	95
Mechanical Problem	91	91
Failure to Advance	91	92
Fracture	46	46
Adverse Event Without Identified Device or Use Problem	41	41
Physical Resistance/Sticking	34	34
Naturally Worn	34	34
Migration or Expulsion of Device	31	31
Scratched Material	28	28
Degraded	27	27
Structural Problem	23	23
Detachment of Device or Device Component	22	22
Insufficient Information	17	17
Unstable	12	12
No Apparent Adverse Event	9	9
Retraction Problem	7	7
Migration	6	6
Material Erosion	5	5
Material Protrusion/Extrusion	5	5
Material Discolored	3	3
Material Twisted/Bent	3	3
Noise, Audible	3	3
Loosening of Implant Not Related to Bone-Ingrowth	2	2
Dent in Material	2	2
Activation, Positioning or Separation Problem	1	1
Malposition of Device	1	1
Unintended Movement	1	1
Defective Device	1	1
Therapeutic or Diagnostic Output Failure	1	1
Material Fragmentation	1	1
Component Missing	1	1
Material Deformation	1	1
Appropriate Term/Code Not Available	1	1
Fluid/Blood Leak	1	1
Failure to Seal	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Failure of Implant	381	382
No Clinical Signs, Symptoms or Conditions	72	72
Insufficient Information	47	48
Metal Related Pathology	28	28
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	24	24
Pain	12	12
Unspecified Infection	8	8
Skin Discoloration	5	5
Inflammation	4	4
Purulent Discharge	4	4
Fever	4	4
Drug Resistant Bacterial Infection	3	3
Necrosis	2	2
Implant Pain	2	2
Localized Skin Lesion	2	2
Ossification	2	2
Burning Sensation	2	2
Joint Laxity	2	2
Bacterial Infection	2	2
Hemorrhage/Bleeding	2	2
Deformity/ Disfigurement	2	2
Spinal Cord Injury	2	2
Decreased Appetite	2	2
Wound Dehiscence	1	1
Sepsis	1	1
Local Reaction	1	1
Foreign Body Reaction	1	1
Post Operative Wound Infection	1	1
Skin Erosion	1	1
Infiltration into Tissue	1	1

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