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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, intervertebral disc
Product CodeMJO
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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