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TPLC
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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
49
49
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
604
604
Break
162
162
Migration
145
145
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
45
45
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
Use of Device Problem
19
19
Material Separation
19
19
Mechanical Problem
17
17
Compatibility Problem
12
12
Fluid/Blood Leak
11
11
Entrapment of Device
11
11
Physical Resistance/Sticking
9
9
Material Fragmentation
8
8
Product Quality Problem
8
8
Improper Chemical Reaction
5
5
Device Handling Problem
5
5
Difficult to Advance
4
4
Difficult to Remove
4
4
Mechanics Altered
4
4
Noise, Audible
3
3
Loss of or Failure to Bond
3
3
Improper or Incorrect Procedure or Method
3
3
Activation, Positioning or Separation Problem
3
3
Inaccurate Information
3
3
Manufacturing, Packaging or Shipping Problem
3
3
Mechanical Jam
2
2
Material Protrusion/Extrusion
2
2
Positioning Failure
2
2
Positioning Problem
2
2
Malposition of Device
2
2
Output Problem
2
2
Inflation Problem
1
1
Component Missing
1
1
Difficult to Insert
1
1
Expulsion
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Insufficient Information
345
345
No Clinical Signs, Symptoms or Conditions
285
285
Pain
201
201
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
94
94
Injury
70
70
Post Operative Wound Infection
68
68
Bone Fracture(s)
67
67
Unspecified Infection
65
65
Nerve Damage
62
62
Osteolysis
60
60
Unspecified Tissue Injury
53
53
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
Deformity/ Disfigurement
9
9
Discomfort
9
9
Neck Pain
9
9
Fall
8
8
Numbness
8
8
Decreased Sensitivity
8
8
Thromboembolism
8
8
Fatigue
7
7
Wound Dehiscence
7
7
Loss of Range of Motion
6
6
Implant Pain
6
6
Stenosis
5
5
Tissue Damage
5
5
Muscular Rigidity
5
5
Hypersensitivity/Allergic reaction
4
4
Speech Disorder
3
3
Device Embedded In Tissue or Plaque
3
3
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