Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
Back to Search Results
Device
orthosis, spondylolisthesis spinal fixation
Regulation Description
Thoracolumbosacral pedicle screw system.
Product Code
MNH
Regulation Number
888.3070
Device Class
2
MDR Year
MDR Reports
MDR Events
2020
432
432
2021
543
543
2022
266
266
2023
122
122
2024
303
303
2025
67
67
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
619
619
Break
162
162
Migration
146
146
Loose or Intermittent Connection
106
106
Device Slipped
74
74
No Apparent Adverse Event
62
62
Insufficient Information
52
52
Unintended Movement
52
52
Appropriate Term/Code Not Available
51
51
Fracture
48
48
Material Integrity Problem
46
46
Device-Device Incompatibility
45
45
Patient Device Interaction Problem
39
39
Loosening of Implant Not Related to Bone-Ingrowth
37
37
Material Twisted/Bent
33
33
Detachment of Device or Device Component
32
32
Migration or Expulsion of Device
31
31
Material Deformation
30
30
Device Dislodged or Dislocated
27
27
Human-Device Interface Problem
19
19
Material Separation
19
19
Use of Device Problem
19
19
Mechanical Problem
17
17
Compatibility Problem
12
12
Entrapment of Device
11
11
Fluid/Blood Leak
11
11
Physical Resistance/Sticking
9
9
Product Quality Problem
8
8
Material Fragmentation
8
8
Improper Chemical Reaction
6
6
Device Handling Problem
5
5
Mechanics Altered
4
4
Difficult to Remove
4
4
Difficult to Advance
4
4
Manufacturing, Packaging or Shipping Problem
3
3
Noise, Audible
3
3
Inaccurate Information
3
3
Loss of or Failure to Bond
3
3
Activation, Positioning or Separation Problem
3
3
Improper or Incorrect Procedure or Method
3
3
Material Protrusion/Extrusion
2
2
Mechanical Jam
2
2
Output Problem
2
2
Positioning Problem
2
2
Positioning Failure
2
2
Malposition of Device
2
2
Installation-Related Problem
1
1
Expulsion
1
1
Connection Problem
1
1
Deformation Due to Compressive Stress
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Insufficient Information
347
347
No Clinical Signs, Symptoms or Conditions
285
285
Pain
217
217
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
173
173
No Code Available
155
155
Failure of Implant
142
142
Non-union Bone Fracture
95
95
Injury
70
70
Post Operative Wound Infection
68
68
Bone Fracture(s)
67
67
Unspecified Infection
66
66
Nerve Damage
62
62
Osteolysis
60
60
Unspecified Tissue Injury
54
54
Spinal Column Injury
53
53
No Consequences Or Impact To Patient
51
51
Hematoma
44
44
Neurological Deficit/Dysfunction
39
39
Spinal Cord Injury
30
30
Cerebrospinal Fluid Leakage
29
29
Dysphagia/ Odynophagia
26
26
Hypoesthesia
23
23
Physical Asymmetry
22
22
Unspecified Nervous System Problem
19
19
Paralysis
19
19
Joint Laxity
17
17
Death
16
16
Foreign Body In Patient
14
14
Impaired Healing
13
13
No Patient Involvement
12
12
Perforation of Vessels
11
11
Hemorrhage/Bleeding
10
10
No Known Impact Or Consequence To Patient
10
10
Discomfort
9
9
Deformity/ Disfigurement
9
9
Neck Pain
9
9
Numbness
8
8
Fall
8
8
Thromboembolism
8
8
Decreased Sensitivity
8
8
Fatigue
7
7
Wound Dehiscence
7
7
Loss of Range of Motion
6
6
Implant Pain
6
6
Stenosis
5
5
Muscular Rigidity
5
5
Tissue Damage
5
5
Hypersensitivity/Allergic reaction
4
4
Device Embedded In Tissue or Plaque
3
3
Speech Disorder
3
3
-
-