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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
149
149
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
318
318
Insufficient Information
262
262
Migration
253
253
Patient-Device Incompatibility
210
210
Patient Device Interaction Problem
141
141
Detachment of Device or Device Component
116
116
Migration or Expulsion of Device
70
70
Collapse
56
56
Appropriate Term/Code Not Available
55
55
Expulsion
52
52
Malposition of Device
50
50
Positioning Problem
36
36
Fracture
33
33
Loosening of Implant Not Related to Bone-Ingrowth
32
32
Osseointegration Problem
31
31
Device Dislodged or Dislocated
31
31
Break
29
29
Disconnection
26
26
Mechanical Problem
24
24
Inadequacy of Device Shape and/or Size
24
24
Device Handling Problem
24
24
Biocompatibility
20
20
Misassembled
19
19
Improper or Incorrect Procedure or Method
17
17
Unintended Movement
17
17
Use of Device Problem
13
13
Physical Resistance/Sticking
13
13
No Apparent Adverse Event
12
12
Device-Device Incompatibility
11
11
Off-Label Use
10
10
Material Fragmentation
10
10
Mechanical Jam
9
9
Material Twisted/Bent
8
8
Compatibility Problem
8
8
Material Separation
8
8
Failure to Osseointegrate
7
7
Loss of Osseointegration
7
7
Positioning Failure
7
7
Failure to Align
7
7
Unstable
6
6
Loose or Intermittent Connection
6
6
Component Missing
5
5
Naturally Worn
5
5
Material Deformation
4
4
Device Slipped
4
4
Material Disintegration
3
3
Therapeutic or Diagnostic Output Failure
3
3
Noise, Audible
3
3
Mechanics Altered
3
3
Output Problem
2
2
Packaging Problem
2
2
Material Integrity Problem
2
2
Installation-Related Problem
2
2
Entrapment of Device
2
2
Unintended System Motion
2
2
Difficult to Remove
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
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
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
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Pain
325
325
Neck Pain
219
219
Insufficient Information
205
205
No Clinical Signs, Symptoms or Conditions
150
150
No Code Available
136
136
Osteolysis
125
125
No Known Impact Or Consequence To Patient
122
122
Ossification
112
112
Failure of Implant
93
93
No Consequences Or Impact To Patient
91
91
No Information
62
62
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
57
57
Unspecified Infection
55
55
Numbness
37
37
Dysphagia/ Odynophagia
36
36
Patient Problem/Medical Problem
29
29
Loss of Range of Motion
23
23
Hypersensitivity/Allergic reaction
19
19
Stenosis
18
18
Implant Pain
18
18
Inadequate Pain Relief
18
18
Joint Laxity
17
17
Vertebral Fracture
17
17
Inflammation
17
17
Paralysis
16
16
Spinal Column Injury
16
16
Nerve Damage
15
15
Muscle Weakness
14
14
Bone Fracture(s)
13
13
Joint Disorder
13
13
Metal Related Pathology
12
12
Neuropathy
12
12
Fall
11
11
Foreign Body In Patient
10
10
Unspecified Blood or Lymphatic problem
9
9
Headache
9
9
Bacterial Infection
8
8
Neuralgia
8
8
Discomfort
8
8
Spinal Cord Injury
7
7
Cramp(s) /Muscle Spasm(s)
7
7
Abscess
7
7
Paresis
7
7
Rash
7
7
Intervertebral Disc Compression or Protrusion
6
6
Peripheral Nervous Injury
6
6
Decreased Sensitivity
6
6
Quadriplegia
6
6
Inadequate Osseointegration
6
6
Osteopenia/ Osteoporosis
6
6
Dyskinesia
6
6
Peritonitis
6
6
Disability
6
6
Joint Dislocation
6
6
Injury
5
5
Ambulation Difficulties
5
5
Post Operative Wound Infection
5
5
Reaction
5
5
No Patient Involvement
5
5
Paresthesia
5
5
Unspecified Musculoskeletal problem
5
5
Unspecified Tissue Injury
5
5
Weakness
5
5
Dysphasia
5
5
Erosion
5
5
Erythema
5
5
Fatigue
5
5
Hemorrhage/Bleeding
4
4
High Blood Pressure/ Hypertension
4
4
Apnea
4
4
Cyst(s)
4
4
Adhesion(s)
4
4
Cramp(s)
4
4
Burning Sensation
4
4
Osteomyelitis
4
4
Subluxation
4
4
Swollen Lymph Nodes/Glands
4
4
Speech Disorder
4
4
Paraplegia
4
4
Limited Mobility Of The Implanted Joint
4
4
Shaking/Tremors
4
4
Hypoesthesia
4
4
Non-union Bone Fracture
4
4
Neck Stiffness
3
3
Dizziness
3
3
Scar Tissue
3
3
Therapeutic Response, Decreased
3
3
Muscle Spasm(s)
3
3
Calcium Deposits/Calcification
3
3
Cerebrospinal Fluid Leakage
3
3
Arthritis
3
3
Foreign Body Reaction
3
3
Multiple Fractures
3
3
Swelling/ Edema
3
3
Fever
2
2
Extravasation
2
2
Undesired Nerve Stimulation
2
2
Neurological Deficit/Dysfunction
2
2
Visual Disturbances
2
2
Tinnitus
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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