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TPLC
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Device
orthosis, spinal pedicle fixation
Regulation Description
Thoracolumbosacral pedicle screw system.
Product Code
MNI
Regulation Number
888.3070
Device Class
2
MDR Year
MDR Reports
MDR Events
2020
115
115
2021
270
270
2022
215
215
2023
123
123
2024
114
114
2025
22
22
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
369
369
Break
193
193
Device-Device Incompatibility
51
51
Migration
40
40
Fracture
36
36
Device Slipped
35
35
Material Integrity Problem
28
28
Appropriate Term/Code Not Available
27
27
Patient Device Interaction Problem
24
24
Compatibility Problem
22
22
Insufficient Information
21
21
No Apparent Adverse Event
20
20
Entrapment of Device
16
16
Detachment of Device or Device Component
14
14
Material Twisted/Bent
11
11
Mechanical Problem
8
8
Loosening of Implant Not Related to Bone-Ingrowth
6
6
Material Fragmentation
5
5
Patient-Device Incompatibility
4
4
Material Deformation
4
4
Material Split, Cut or Torn
3
3
Positioning Problem
3
3
Loose or Intermittent Connection
2
2
Device Dislodged or Dislocated
2
2
Material Separation
2
2
Difficult to Remove
2
2
Defective Device
2
2
Unintended Movement
2
2
Component or Accessory Incompatibility
2
2
Fitting Problem
2
2
Failure to Osseointegrate
1
1
Device Damaged by Another Device
1
1
Difficult to Advance
1
1
Solder Joint Fracture
1
1
Calibration Problem
1
1
Separation Failure
1
1
Crack
1
1
Physical Resistance/Sticking
1
1
Inadequacy of Device Shape and/or Size
1
1
Malposition of Device
1
1
Migration or Expulsion of Device
1
1
Device Appears to Trigger Rejection
1
1
Improper or Incorrect Procedure or Method
1
1
Deformation Due to Compressive Stress
1
1
Mechanical Jam
1
1
Loss of or Failure to Bond
1
1
Noise, Audible
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
215
215
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
110
110
Insufficient Information
108
108
Non-union Bone Fracture
74
74
Pain
72
72
Post Operative Wound Infection
70
70
Nerve Damage
60
60
Failure of Implant
55
55
Unspecified Tissue Injury
53
53
Osteolysis
45
45
Unspecified Infection
43
43
Bone Fracture(s)
34
34
Joint Laxity
31
31
Cerebrospinal Fluid Leakage
29
29
Perforation of Vessels
29
29
Hematoma
29
29
No Consequences Or Impact To Patient
27
27
No Code Available
26
26
No Known Impact Or Consequence To Patient
24
24
Intervertebral Disc Compression or Protrusion
24
24
Physical Asymmetry
22
22
Decreased Sensitivity
20
20
Vertebral Fracture
17
17
Foreign Body In Patient
16
16
Spinal Cord Injury
15
15
Neuralgia
10
10
Malunion of Bone
9
9
Implant Pain
7
7
Neck Pain
7
7
Impaired Healing
7
7
Thromboembolism
6
6
Loss of Range of Motion
6
6
Necrosis
5
5
Unspecified Nervous System Problem
5
5
Injury
5
5
Thrombosis/Thrombus
5
5
Hemorrhage/Bleeding
5
5
Discomfort
5
5
Device Embedded In Tissue or Plaque
3
3
Ambulation Difficulties
3
3
Burning Sensation
3
3
Numbness
3
3
Hypersensitivity/Allergic reaction
3
3
Synovitis
2
2
Embolism/Embolus
2
2
Seroma
2
2
Deformity/ Disfigurement
2
2
Muscular Rigidity
2
2
Fatigue
2
2
Unspecified Kidney or Urinary Problem
2
2
Recalls
Manufacturer
Recall Class
Date Posted
1
Medicrea International
II
Aug-24-2023
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