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TPLC
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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 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
MDR Year
MDR Reports
MDR Events
2019
86
86
2020
339
339
2021
204
204
2022
120
120
2023
189
189
2024
29
29
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
94
94
Migration or Expulsion of Device
59
59
Adverse Event Without Identified Device or Use Problem
53
53
Fracture
51
51
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
728
728
No Clinical Signs, Symptoms or Conditions
74
74
No Known Impact Or Consequence To Patient
51
51
Insufficient Information
46
46
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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