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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
ELLIPSE TECHNOLOGIES INC.
SUBSTANTIALLY EQUIVALENT
1
ELLIPSE TECHNOLOGIES, INC.
SUBSTANTIALLY EQUIVALENT
2
ELLIPSE TECHNOLOGIES, INCORPORATED
SUBSTANTIALLY EQUIVALENT
1
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
SUBSTANTIALLY EQUIVALENT
3
NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2014
12
12
2015
16
16
2016
18
18
2017
31
31
2018
45
45
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
240
240
Break
163
163
Mechanical Jam
142
142
Mechanical Problem
133
133
Corroded
130
130
Failure to Advance
75
75
Migration or Expulsion of Device
59
59
Adverse Event Without Identified Device or Use Problem
54
54
Fracture
51
51
Migration
43
43
Physical Resistance/Sticking
38
38
Naturally Worn
35
35
Scratched Material
28
28
Degraded
27
27
Structural Problem
27
27
Device Operates Differently Than Expected
26
26
Defective Component
26
26
Detachment of Device or Device Component
22
22
Insufficient Information
21
21
Appropriate Term/Code Not Available
17
17
No Apparent Adverse Event
16
16
Unstable
15
15
Material Separation
15
15
Retraction Problem
9
9
Device Inoperable
6
6
Mechanics Altered
5
5
Material Protrusion/Extrusion
5
5
Material Twisted/Bent
3
3
Therapeutic or Diagnostic Output Failure
3
3
Noise, Audible
3
3
Material Erosion
3
3
Positioning Failure
2
2
Material Discolored
2
2
Detachment Of Device Component
2
2
Dent in Material
2
2
Loosening of Implant Not Related to Bone-Ingrowth
2
2
Separation Problem
1
1
Activation Failure
1
1
Unintended Movement
1
1
Positioning Problem
1
1
Component Missing
1
1
Metal Shedding Debris
1
1
Malposition of Device
1
1
Activation, Positioning or Separation Problem
1
1
Device Operational Issue
1
1
Device Dislodged or Dislocated
1
1
Material Deformation
1
1
Crack
1
1
Electromagnetic Interference
1
1
Fluid/Blood Leak
1
1
Material Fragmentation
1
1
Loose or Intermittent Connection
1
1
Inadequacy of Device Shape and/or Size
1
1
Unexpected Therapeutic Results
1
1
Particulates
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Failure of Implant
726
726
No Clinical Signs, Symptoms or Conditions
74
74
No Known Impact Or Consequence To Patient
73
73
No Code Available
51
51
Insufficient Information
33
33
No Information
32
32
Unspecified Infection
29
29
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
26
26
Metal Related Pathology
24
24
Pain
15
15
Skin Discoloration
7
7
Inflammation
5
5
No Consequences Or Impact To Patient
5
5
Purulent Discharge
4
4
Fever
4
4
Wound Dehiscence
3
3
Ossification
2
2
Bacterial Infection
2
2
Fall
2
2
Therapeutic Response, Decreased
2
2
Deformity/ Disfigurement
2
2
Spinal Cord Injury
2
2
Post Operative Wound Infection
2
2
Necrosis
2
2
Hemorrhage/Bleeding
2
2
Burning Sensation
2
2
Localized Skin Lesion
2
2
Drug Resistant Bacterial Infection
2
2
Implant Pain
2
2
Decreased Appetite
2
2
Joint Laxity
2
2
Patient Problem/Medical Problem
2
2
Skin Erosion
1
1
Swelling
1
1
Tissue Damage
1
1
Cerebral Ventriculomeglia
1
1
Low Oxygen Saturation
1
1
Blood Loss
1
1
Fluid Discharge
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
Bone Fracture(s)
1
1
Headache
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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