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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)
2020 2021 2022 2023 2024 2025
21 17 11 12 13 1

MDR Year MDR Reports MDR Events
2020 345 345
2021 308 308
2022 263 263
2023 278 278
2024 315 315
2025 29 29

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 311 311
Migration 257 257
Insufficient Information 220 220
Patient-Device Incompatibility 181 181
Patient Device Interaction Problem 132 132
Detachment of Device or Device Component 91 91
Migration or Expulsion of Device 68 68
Expulsion 54 54
Collapse 43 43
Appropriate Term/Code Not Available 41 41
Malposition of Device 37 37
Osseointegration Problem 35 35
Loosening of Implant Not Related to Bone-Ingrowth 33 33
Fracture 31 31
Mechanical Problem 24 24
Inadequacy of Device Shape and/or Size 24 24
Biocompatibility 19 19
Device Dislodged or Dislocated 17 17
Unintended Movement 14 14
Positioning Problem 14 14
Use of Device Problem 14 14
Improper or Incorrect Procedure or Method 13 13
Break 13 13
Off-Label Use 10 10
Loss of Osseointegration 10 10
Material Fragmentation 9 9
Physical Resistance/Sticking 9 9
Failure to Align 7 7
Compatibility Problem 7 7
No Apparent Adverse Event 6 6
Failure to Osseointegrate 5 5
Naturally Worn 5 5
Unstable 4 4
Material Deformation 4 4
Scratched Material 3 3
Difficult to Remove 3 3
Therapeutic or Diagnostic Output Failure 3 3
Material Twisted/Bent 3 3
Mechanics Altered 3 3
Material Separation 3 3
Material Split, Cut or Torn 2 2
Device-Device Incompatibility 2 2
Entrapment of Device 2 2
Expiration Date Error 2 2
Structural Problem 2 2
Material Disintegration 2 2
Noise, Audible 2 2
Human-Device Interface Problem 2 2
Output Problem 2 2
Installation-Related Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 290 290
Insufficient Information 239 239
No Clinical Signs, Symptoms or Conditions 192 192
Neck Pain 188 188
Osteolysis 148 148
Ossification 99 99
Failure of Implant 97 97
No Code Available 70 70
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 62 62
Unspecified Infection 55 55
No Known Impact Or Consequence To Patient 39 39
Numbness 35 35
Dysphagia/ Odynophagia 32 32
Implant Pain 26 26
Inflammation 24 24
Inadequate Pain Relief 23 23
Stenosis 20 20
Hypersensitivity/Allergic reaction 20 20
No Information 19 19
Vertebral Fracture 18 18
Spinal Column Injury 17 17
Muscle Weakness 17 17
Joint Laxity 17 17
Loss of Range of Motion 15 15
Nerve Damage 14 14
Paralysis 14 14
Bone Fracture(s) 14 14
Metal Related Pathology 13 13
Joint Disorder 13 13
Neuropathy 12 12
Patient Problem/Medical Problem 12 12
Fall 11 11
Unspecified Musculoskeletal problem 10 10
Unspecified Blood or Lymphatic problem 9 9
Foreign Body In Patient 9 9
No Consequences Or Impact To Patient 9 9
Neuralgia 8 8
Headache 8 8
Spinal Cord Injury 7 7
Bacterial Infection 7 7
Abscess 7 7
Cramp(s) /Muscle Spasm(s) 7 7
Paresis 7 7
Hemorrhage/Bleeding 7 7
Peritonitis 6 6
Erosion 6 6
Ambulation Difficulties 6 6
Intervertebral Disc Compression or Protrusion 6 6
Peripheral Nervous Injury 6 6
Joint Dislocation 6 6

Recalls
Manufacturer Recall Class Date Posted
1 Centinel Spine, Inc. II Sep-24-2024
2 Centinel Spine, Inc. II Apr-09-2021
3 Medicrea International II Aug-24-2023
4 NuVasive Inc II Jul-22-2022
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