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U.S. Department of Health and Human Services

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 CodePGN
Regulation Number 888.3070
Device Class 2


Premarket Reviews
ManufacturerDecision
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 86 86
2020 339 339
2021 204 204
2022 120 120
2023 189 189
2024 25 25

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 123 123
Failure to Advance 91 91
Migration or Expulsion of Device 59 59
Adverse Event Without Identified Device or Use Problem 53 53
Fracture 50 50
Migration 43 43
Physical Resistance/Sticking 39 39
Naturally Worn 35 35
Scratched Material 28 28
Degraded 28 28
Structural Problem 27 27
Defective Component 25 25
Detachment of Device or Device 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 Discolored 3 3
Material Twisted/Bent 3 3
Noise, Audible 3 3
Dent in Material 2 2
Loosening of Implant Not Related to Bone-Ingrowth 2 2
Therapeutic or Diagnostic Output Failure 2 2
Component Missing 1 1
Material Fragmentation 1 1
Particulates 1 1
Material Deformation 1 1
Unintended Movement 1 1
Crack 1 1
Malposition of Device 1 1
Electromagnetic Interference 1 1
Unexpected Therapeutic Results 1 1
Separation Problem 1 1
Activation, Positioning or Separation Problem 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 725 725
No Clinical Signs, Symptoms or Conditions 74 74
No Known Impact Or Consequence To Patient 51 51
Insufficient Information 45 45
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
Inflammation 4 4
Purulent Discharge 4 4
Fever 4 4
Wound Dehiscence 3 3
Decreased Appetite 2 2
Drug Resistant Bacterial Infection 2 2
No Code Available 2 2
Spinal Cord Injury 2 2
Necrosis 2 2
No Information 2 2
Implant Pain 2 2
Localized Skin Lesion 2 2
Ossification 2 2
Deformity/ Disfigurement 2 2
Burning Sensation 2 2
Hemorrhage/Bleeding 2 2
Bacterial Infection 2 2
Joint Laxity 2 2
Low Oxygen Saturation 1 1
No Consequences Or Impact To Patient 1 1
Infiltration into Tissue 1 1
Headache 1 1
Fluid Discharge 1 1
Cerebral Ventriculomeglia 1 1
Fall 1 1
Swelling 1 1
Skin Erosion 1 1
Burn(s) 1 1
Post Operative Wound Infection 1 1
Foreign Body Reaction 1 1
Blood Loss 1 1
Local Reaction 1 1
Sepsis 1 1
Seizures 1 1
Patient Problem/Medical Problem 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
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