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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 7

MDR Year MDR Reports MDR Events
2019 380 380
2020 345 345
2021 308 308
2022 265 265
2023 278 278
2024 175 175

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 324 324
Insufficient Information 271 271
Migration 254 254
Patient-Device Incompatibility 210 210
Patient Device Interaction Problem 141 141
Detachment of Device or Device Component 117 117
Migration or Expulsion of Device 70 70
Collapse 57 57
Appropriate Term/Code Not Available 55 55
Expulsion 52 52
Malposition of Device 50 50
Positioning Problem 36 36
Fracture 34 34
Osseointegration Problem 33 33
Loosening of Implant Not Related to Bone-Ingrowth 32 32
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 14 14
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
Loss of Osseointegration 9 9
Mechanical Jam 9 9
Material Twisted/Bent 8 8
Compatibility Problem 8 8
Material Separation 8 8
Failure to Osseointegrate 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
Crack 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 332 332
Neck Pain 222 222
Insufficient Information 210 210
No Clinical Signs, Symptoms or Conditions 153 153
No Code Available 136 136
Osteolysis 134 134
No Known Impact Or Consequence To Patient 122 122
Ossification 112 112
Failure of Implant 95 95
No Consequences Or Impact To Patient 91 91
No Information 62 62
Unspecified Infection 59 59
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 58 58
Numbness 41 41
Dysphagia/ Odynophagia 36 36
Patient Problem/Medical Problem 29 29
Loss of Range of Motion 23 23
Hypersensitivity/Allergic reaction 19 19
Inflammation 18 18
Stenosis 18 18
Inadequate Pain Relief 18 18
Implant Pain 18 18
Vertebral Fracture 17 17
Joint Laxity 17 17
Paralysis 16 16
Muscle Weakness 16 16
Spinal Column Injury 16 16
Nerve Damage 15 15
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
Dysphasia 6 6
Peritonitis 6 6
Intervertebral Disc Compression or Protrusion 6 6
Unspecified Musculoskeletal problem 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
Joint Dislocation 6 6
Disability 6 6
Reaction 5 5
Injury 5 5
Post Operative Wound Infection 5 5
Ambulation Difficulties 5 5
No Patient Involvement 5 5
Unspecified Tissue Injury 5 5
Paresthesia 5 5
Weakness 5 5
Erosion 5 5
Erythema 5 5
Fatigue 5 5
High Blood Pressure/ Hypertension 4 4
Hemorrhage/Bleeding 4 4
Apnea 4 4
Cyst(s) 4 4
Adhesion(s) 4 4
Burning Sensation 4 4
Cramp(s) 4 4
Swollen Lymph Nodes/Glands 4 4
Osteomyelitis 4 4
Subluxation 4 4
Limited Mobility Of The Implanted Joint 4 4
Speech Disorder 4 4
Paraplegia 4 4
Shaking/Tremors 4 4
Hypoesthesia 4 4
Non-union Bone Fracture 4 4
Swelling/ Edema 4 4
Therapeutic Response, Decreased 3 3
Neck Stiffness 3 3
Multiple Fractures 3 3
Dizziness 3 3
Scar Tissue 3 3
Calcium Deposits/Calcification 3 3
Cerebrospinal Fluid Leakage 3 3
Arthritis 3 3
Muscle Spasm(s) 3 3
Foreign Body Reaction 3 3
Fever 2 2
Memory Loss/Impairment 2 2
Extravasation 2 2
Dyspnea 2 2
Tinnitus 2 2
Tissue Damage 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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