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TPLC
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show TPLC since
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2024
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Device
orthosis, spinal pedicle fixation
Product Code
MNI
Regulation Number
888.3070
Device Class
2
MDR Year
MDR Reports
MDR Events
2019
188
188
2020
115
115
2021
274
274
2022
215
215
2023
123
123
2024
104
104
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
427
427
Break
205
205
Migration
52
52
Device-Device Incompatibility
51
51
Fracture
49
49
No Apparent Adverse Event
43
43
Device Slipped
38
38
Appropriate Term/Code Not Available
34
34
Material Integrity Problem
34
34
Insufficient Information
29
29
Patient Device Interaction Problem
29
29
Detachment of Device or Device Component
21
21
Compatibility Problem
17
17
Entrapment of Device
16
16
Material Separation
14
14
Material Twisted/Bent
11
11
Loosening of Implant Not Related to Bone-Ingrowth
11
11
Material Deformation
10
10
Mechanical Problem
8
8
Mechanical Jam
6
6
Material Split, Cut or Torn
6
6
Migration or Expulsion of Device
6
6
Device Dislodged or Dislocated
5
5
Material Fragmentation
5
5
Unintended Movement
5
5
Structural Problem
4
4
Patient-Device Incompatibility
4
4
Improper or Incorrect Procedure or Method
4
4
Positioning Problem
3
3
Component or Accessory Incompatibility
3
3
Fitting Problem
3
3
Difficult to Remove
2
2
Manufacturing, Packaging or Shipping Problem
2
2
Defective Device
2
2
Use of Device Problem
2
2
Product Quality Problem
2
2
Inadequacy of Device Shape and/or Size
2
2
Physical Resistance/Sticking
2
2
Loose or Intermittent Connection
2
2
Difficult to Advance
1
1
Device Damaged by Another Device
1
1
Separation Failure
1
1
Misassembled
1
1
Solder Joint Fracture
1
1
Calibration Problem
1
1
Packaging Problem
1
1
Misassembly by Users
1
1
Crack
1
1
Output Problem
1
1
Malposition of Device
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
199
199
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
112
112
Insufficient Information
101
101
Pain
95
95
Nerve Damage
76
76
Non-union Bone Fracture
75
75
Failure of Implant
74
74
No Code Available
74
74
Post Operative Wound Infection
71
71
No Known Impact Or Consequence To Patient
56
56
Unspecified Infection
53
53
Unspecified Tissue Injury
53
53
Osteolysis
50
50
Bone Fracture(s)
40
40
No Consequences Or Impact To Patient
34
34
Hematoma
33
33
Joint Laxity
31
31
Perforation of Vessels
29
29
Cerebrospinal Fluid Leakage
29
29
Intervertebral Disc Compression or Protrusion
24
24
Physical Asymmetry
22
22
Decreased Sensitivity
20
20
Vertebral Fracture
17
17
Foreign Body In Patient
17
17
No Information
16
16
Spinal Cord Injury
15
15
Impaired Healing
13
13
Limited Mobility Of The Implanted Joint
10
10
Neuralgia
10
10
Injury
9
9
Malunion of Bone
9
9
Joint Disorder
8
8
Neck Pain
8
8
Necrosis
7
7
Implant Pain
7
7
Discomfort
7
7
Thromboembolism
6
6
Loss of Range of Motion
6
6
Device Embedded In Tissue or Plaque
6
6
Hemorrhage/Bleeding
5
5
Not Applicable
5
5
Unspecified Nervous System Problem
5
5
Thrombosis/Thrombus
5
5
Spinal Column Injury
4
4
Neurological Deficit/Dysfunction
3
3
Seroma
3
3
Ambulation Difficulties
3
3
Deformity/ Disfigurement
2
2
Stenosis
2
2
Pulmonary Embolism
2
2
Recalls
Manufacturer
Recall Class
Date Posted
1
CTL Medical Corporation
II
Mar-20-2019
2
Medicrea International
II
Aug-24-2023
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