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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 121 121

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 316 316
Insufficient Information 258 258
Migration 246 246
Patient-Device Incompatibility 203 203
Patient Device Interaction Problem 141 141
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
Loosening of Implant Not Related to Bone-Ingrowth 32 32
Device Dislodged or Dislocated 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
Improper or Incorrect Procedure or Method 17 17
Unintended Movement 17 17
Use of Device Problem 13 13
Physical Resistance/Sticking 12 12
No Apparent Adverse Event 12 12
Off-Label Use 10 10
Material Fragmentation 10 10
Device-Device Incompatibility 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 320 320
Neck Pain 214 214
Insufficient Information 203 203
No Clinical Signs, Symptoms or Conditions 147 147
No Code Available 136 136
No Known Impact Or Consequence To Patient 122 122
Osteolysis 121 121
Ossification 110 110
No Consequences Or Impact To Patient 91 91
Failure of Implant 83 83
No Information 62 62
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 57 57
Unspecified Infection 55 55
Dysphagia/ Odynophagia 36 36
Numbness 35 35
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
Vertebral Fracture 17 17
Joint Laxity 17 17
Paralysis 16 16
Spinal Column Injury 16 16
Nerve Damage 15 15
Inflammation 15 15
Muscle Weakness 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
Bacterial Infection 8 8
Abscess 7 7
Paresis 7 7
Rash 7 7
Cramp(s) /Muscle Spasm(s) 7 7
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
Peritonitis 6 6
Headache 6 6
Fatigue 5 5
Erosion 5 5
Erythema 5 5
Dysphasia 5 5
Weakness 5 5
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
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
Burning Sensation 4 4
Cramp(s) 4 4
Apnea 4 4
Cyst(s) 4 4
Adhesion(s) 4 4
Hemorrhage/Bleeding 4 4
High Blood Pressure/ Hypertension 4 4
Foreign Body Reaction 3 3
Calcium Deposits/Calcification 3 3
Cerebrospinal Fluid Leakage 3 3
Arthritis 3 3
Therapeutic Response, Decreased 3 3
Muscle Spasm(s) 3 3
Scar Tissue 3 3
Neck Stiffness 3 3
Multiple Fractures 3 3
Swelling/ Edema 3 3
Fecal Incontinence 2 2
Urinary Incontinence 2 2
Unspecified Respiratory Problem 2 2
Unspecified Eye / Vision Problem 2 2
Device Embedded In Tissue or Plaque 2 2
Post Traumatic Wound Infection 2 2
Irregular Pulse 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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