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TPLC
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show TPLC since
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2024
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Device
prosthesis, intervertebral disc
Product Code
MJO
Device Class
3
Premarket Approvals (PMA)
2019
2020
2021
2022
2023
2024
12
21
17
11
12
5
MDR Year
MDR Reports
MDR Events
2019
380
380
2020
345
345
2021
308
308
2022
265
265
2023
278
278
2024
91
91
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
312
312
Insufficient Information
250
250
Migration
234
234
Patient-Device Incompatibility
203
203
Patient Device Interaction Problem
140
140
Detachment of Device or Device Component
115
115
Migration or Expulsion of Device
69
69
Appropriate Term/Code Not Available
55
55
Expulsion
52
52
Collapse
51
51
Malposition of Device
50
50
Positioning Problem
35
35
Fracture
33
33
Device Dislodged or Dislocated
31
31
Loosening of Implant Not Related to Bone-Ingrowth
31
31
Break
29
29
Osseointegration Problem
28
28
Disconnection
26
26
Inadequacy of Device Shape and/or Size
24
24
Device Handling Problem
24
24
Mechanical Problem
23
23
Biocompatibility
20
20
Misassembled
19
19
Unintended Movement
17
17
Improper or Incorrect Procedure or Method
15
15
Use of Device Problem
13
13
Physical Resistance/Sticking
12
12
No Apparent Adverse Event
12
12
Material Fragmentation
10
10
Device-Device Incompatibility
10
10
Mechanical Jam
9
9
Off-Label Use
9
9
Material Separation
8
8
Material Twisted/Bent
8
8
Compatibility Problem
8
8
Failure to Align
7
7
Failure to Osseointegrate
7
7
Loss of Osseointegration
7
7
Positioning Failure
7
7
Loose or Intermittent Connection
6
6
Unstable
6
6
Component Missing
5
5
Device Slipped
4
4
Material Deformation
4
4
Naturally Worn
4
4
Therapeutic or Diagnostic Output Failure
3
3
Noise, Audible
3
3
Mechanics Altered
3
3
Material Disintegration
3
3
Entrapment of Device
2
2
Unintended System Motion
2
2
Difficult to Remove
2
2
Output Problem
2
2
Packaging Problem
2
2
Material Integrity Problem
2
2
Installation-Related Problem
2
2
Misassembled During Installation
2
2
Material Split, Cut or Torn
2
2
Device Fell
1
1
Activation Problem
1
1
Difficult or Delayed Separation
1
1
Unclear Information
1
1
Human-Device Interface Problem
1
1
Material Protrusion/Extrusion
1
1
Failure to Disconnect
1
1
Defective Device
1
1
Deformation Due to Compressive Stress
1
1
Scratched Material
1
1
Misassembly by Users
1
1
Material Rupture
1
1
Product Quality Problem
1
1
Unraveled Material
1
1
Incomplete or Missing Packaging
1
1
Dull, Blunt
1
1
Structural Problem
1
1
Defective Component
1
1
Flaked
1
1
Complete Blockage
1
1
Component Falling
1
1
Delivered as Unsterile Product
1
1
Partial Blockage
1
1
Difficult to Insert
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Pain
314
314
Neck Pain
203
203
Insufficient Information
197
197
No Clinical Signs, Symptoms or Conditions
143
143
No Code Available
136
136
No Known Impact Or Consequence To Patient
122
122
Osteolysis
110
110
Ossification
108
108
No Consequences Or Impact To Patient
91
91
Failure of Implant
82
82
No Information
62
62
Unspecified Infection
55
55
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
55
55
Dysphagia/ Odynophagia
35
35
Numbness
34
34
Patient Problem/Medical Problem
29
29
Loss of Range of Motion
21
21
Hypersensitivity/Allergic reaction
19
19
Stenosis
18
18
Inadequate Pain Relief
18
18
Joint Laxity
16
16
Paralysis
16
16
Spinal Column Injury
16
16
Inflammation
15
15
Vertebral Fracture
15
15
Muscle Weakness
14
14
Nerve Damage
14
14
Bone Fracture(s)
13
13
Joint Disorder
13
13
Metal Related Pathology
12
12
Implant Pain
12
12
Neuropathy
12
12
Fall
11
11
Foreign Body In Patient
10
10
Unspecified Blood or Lymphatic problem
9
9
Neuralgia
8
8
Discomfort
8
8
Cramp(s) /Muscle Spasm(s)
7
7
Abscess
7
7
Paresis
7
7
Rash
7
7
Peritonitis
6
6
Bacterial Infection
6
6
Headache
6
6
Intervertebral Disc Compression or Protrusion
6
6
Peripheral Nervous Injury
6
6
Decreased Sensitivity
6
6
Joint Dislocation
6
6
Dyskinesia
6
6
Disability
6
6
Spinal Cord Injury
6
6
Quadriplegia
6
6
Inadequate Osseointegration
6
6
Osteopenia/ Osteoporosis
6
6
Ambulation Difficulties
5
5
Post Operative Wound Infection
5
5
Reaction
5
5
Injury
5
5
No Patient Involvement
5
5
Paresthesia
5
5
Unspecified Musculoskeletal problem
5
5
Unspecified Tissue Injury
5
5
Fatigue
5
5
Erosion
5
5
Erythema
5
5
Dysphasia
5
5
Weakness
5
5
Burning Sensation
4
4
Cramp(s)
4
4
Apnea
4
4
Adhesion(s)
4
4
Hemorrhage/Bleeding
4
4
High Blood Pressure/ Hypertension
4
4
Osteomyelitis
4
4
Subluxation
4
4
Swollen Lymph Nodes/Glands
4
4
Speech Disorder
4
4
Limited Mobility Of The Implanted Joint
4
4
Hypoesthesia
4
4
Non-union Bone Fracture
4
4
Paraplegia
4
4
Shaking/Tremors
4
4
Neck Stiffness
3
3
Multiple Fractures
3
3
Swelling/ Edema
3
3
Foreign Body Reaction
3
3
Calcium Deposits/Calcification
3
3
Cerebrospinal Fluid Leakage
3
3
Arthritis
3
3
Cyst(s)
3
3
Therapeutic Response, Decreased
3
3
Muscle Spasm(s)
3
3
Scar Tissue
3
3
Visual Disturbances
2
2
Tinnitus
2
2
Tissue Damage
2
2
Undesired Nerve Stimulation
2
2
Neurological Deficit/Dysfunction
2
2
Dizziness
2
2
Tingling
2
2
Recalls
Manufacturer
Recall Class
Date Posted
1
Centinel Spine, Inc.
II
Apr-09-2021
2
Medicrea International
II
Aug-24-2023
3
NuVasive Inc
II
Jul-22-2022
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