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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 7 7

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 120 120
Failure to Advance 74 74
Migration or Expulsion of Device 59 59
Adverse Event Without Identified Device or Use Problem 53 53
Fracture 49 49
Migration 43 43
Physical Resistance/Sticking 38 38
Naturally Worn 35 35
Scratched Material 28 28
Structural Problem 27 27
Degraded 27 27
Defective Component 25 25
Detachment of Device or Device Component 22 22
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 Twisted/Bent 3 3
Material Erosion 3 3
Noise, Audible 3 3
Loosening of Implant Not Related to Bone-Ingrowth 2 2
Material Discolored 2 2
Dent in Material 2 2
Therapeutic or Diagnostic Output Failure 2 2
Unintended Movement 1 1
Malposition of Device 1 1
Activation, Positioning or Separation Problem 1 1
Material Deformation 1 1
Electromagnetic Interference 1 1
Crack 1 1
Fluid/Blood Leak 1 1
Material Fragmentation 1 1
Unexpected Therapeutic Results 1 1
Particulates 1 1
Component Missing 1 1
Separation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Failure of Implant 717 717
No Clinical Signs, Symptoms or Conditions 74 74
No Known Impact Or Consequence To Patient 51 51
Insufficient Information 33 33
Unspecified Infection 26 26
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 25 25
Metal Related Pathology 24 24
Pain 14 14
Skin Discoloration 5 5
Inflammation 4 4
Purulent Discharge 4 4
Fever 4 4
Wound Dehiscence 3 3
Ossification 2 2
Bacterial Infection 2 2
Necrosis 2 2
Deformity/ Disfigurement 2 2
Spinal Cord Injury 2 2
Localized Skin Lesion 2 2
Drug Resistant Bacterial Infection 2 2
Implant Pain 2 2
Decreased Appetite 2 2
No Information 2 2
No Code Available 2 2
Joint Laxity 2 2
Burning Sensation 2 2
Hemorrhage/Bleeding 2 2
No Consequences Or Impact To Patient 1 1
Post Operative Wound Infection 1 1
Low Oxygen Saturation 1 1
Blood Loss 1 1
Fluid Discharge 1 1
Patient Problem/Medical Problem 1 1
Skin Erosion 1 1
Swelling 1 1
Cerebral Ventriculomeglia 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
Headache 1 1
Fall 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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