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TPLC
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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
2018
134
134
2019
188
188
2020
115
115
2021
274
274
2022
215
215
2023
111
111
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
391
391
Break
234
234
Fracture
63
63
Device-Device Incompatibility
54
54
Migration
49
49
No Apparent Adverse Event
40
40
Device Slipped
40
40
Appropriate Term/Code Not Available
38
38
Material Integrity Problem
36
36
Material Separation
29
29
Detachment of Device or Device Component
24
24
Patient Device Interaction Problem
21
21
Insufficient Information
20
20
Material Fragmentation
17
17
Entrapment of Device
16
16
Compatibility Problem
15
15
Material Twisted/Bent
14
14
Loosening of Implant Not Related to Bone-Ingrowth
12
12
Material Deformation
11
11
Mechanical Problem
9
9
Migration or Expulsion of Device
8
8
Failure To Adhere Or Bond
8
8
Device Operational Issue
8
8
Unintended Movement
8
8
Mechanical Jam
6
6
Material Split, Cut or Torn
6
6
Device Dislodged or Dislocated
6
6
Improper or Incorrect Procedure or Method
5
5
Fitting Problem
4
4
Structural Problem
4
4
Patient-Device Incompatibility
4
4
Device Operates Differently Than Expected
4
4
Component or Accessory Incompatibility
3
3
Use of Device Problem
3
3
Malposition of Device
3
3
Loose or Intermittent Connection
3
3
Positioning Problem
3
3
Physical Resistance/Sticking
2
2
Manufacturing, Packaging or Shipping Problem
2
2
Difficult to Insert
2
2
Loss of or Failure to Bond
2
2
Product Quality Problem
2
2
Difficult to Remove
2
2
Inadequacy of Device Shape and/or Size
2
2
Separation Failure
2
2
Defective Device
2
2
Solder Joint Fracture
1
1
Deformation Due to Compressive Stress
1
1
Calibration Problem
1
1
Difficult to Advance
1
1
Device Damaged by Another Device
1
1
Inadequate or Insufficient Training
1
1
Misassembled
1
1
Crack
1
1
Disconnection
1
1
Measurement System Incompatibility
1
1
Output Problem
1
1
Packaging Problem
1
1
Misassembly by Users
1
1
Noise, Audible
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
172
172
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
112
112
Pain
105
105
No Code Available
103
103
Failure of Implant
84
84
No Known Impact Or Consequence To Patient
77
77
Non-union Bone Fracture
63
63
Nerve Damage
59
59
Post Operative Wound Infection
58
58
Insufficient Information
55
55
Unspecified Tissue Injury
48
48
No Information
43
43
No Consequences Or Impact To Patient
43
43
Unspecified Infection
37
37
Osteolysis
37
37
Bone Fracture(s)
30
30
Perforation of Vessels
27
27
Intervertebral Disc Compression or Protrusion
24
24
Hematoma
23
23
Physical Asymmetry
20
20
Foreign Body In Patient
18
18
Not Applicable
15
15
Cerebrospinal Fluid Leakage
15
15
Vertebral Fracture
15
15
Injury
14
14
Device Embedded In Tissue or Plaque
12
12
Discomfort
11
11
Spinal Cord Injury
11
11
Limited Mobility Of The Implanted Joint
10
10
Neuralgia
10
10
Spinal Column Injury
10
10
Decreased Sensitivity
9
9
Impaired Healing
9
9
Malunion of Bone
9
9
Joint Laxity
8
8
Neck Pain
8
8
Joint Disorder
8
8
Sudden Cardiac Death
8
8
Necrosis
7
7
Hemorrhage/Bleeding
5
5
Implant Pain
4
4
Neurological Deficit/Dysfunction
3
3
Ambulation Difficulties
3
3
Unspecified Nervous System Problem
3
3
Patient Problem/Medical Problem
2
2
Thromboembolism
2
2
Numbness
2
2
Complaint, Ill-Defined
2
2
Muscular Rigidity
2
2
Wound Dehiscence
2
2
Fall
2
2
Fatigue
2
2
Seroma
2
2
Synovitis
2
2
Stenosis
2
2
Anxiety
1
1
Excessive Tear Production
1
1
Thrombosis
1
1
Urinary Tract Infection
1
1
Visual Impairment
1
1
Weakness
1
1
Swelling
1
1
Paralysis
1
1
Paresis
1
1
Rash
1
1
Scarring
1
1
Sepsis
1
1
Fistula
1
1
Pulmonary Embolism
1
1
Anemia
1
1
Cyst(s)
1
1
Death
1
1
Erythema
1
1
Hypersensitivity/Allergic reaction
1
1
Hypoesthesia
1
1
Respiratory Tract Infection
1
1
Cognitive Changes
1
1
No Patient Involvement
1
1
Vascular Dissection
1
1
Embolism/Embolus
1
1
Thrombosis/Thrombus
1
1
Balance Problems
1
1
Swelling/ Edema
1
1
Unspecified Musculoskeletal problem
1
1
Skin Inflammation/ Irritation
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
CTL Medical Corporation
II
Mar-20-2019
2
Medicrea International
II
Aug-24-2023
3
New Era Orthopaedics, LLc
II
Aug-03-2018
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