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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 10

MDR Year MDR Reports MDR Events
2019 380 380
2020 345 345
2021 308 308
2022 265 265
2023 278 278
2024 245 245

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 343 343
Insufficient Information 285 285
Migration 274 274
Patient-Device Incompatibility 210 210
Patient Device Interaction Problem 144 144
Detachment of Device or Device Component 123 123
Migration or Expulsion of Device 72 72
Collapse 57 57
Appropriate Term/Code Not Available 56 56
Expulsion 55 55
Malposition of Device 53 53
Fracture 39 39
Positioning Problem 36 36
Loosening of Implant Not Related to Bone-Ingrowth 35 35
Osseointegration Problem 33 33
Device Dislodged or Dislocated 32 32
Break 29 29
Disconnection 26 26
Inadequacy of Device Shape and/or Size 25 25
Mechanical Problem 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 12 12
Off-Label Use 10 10
Material Fragmentation 10 10
Mechanical Jam 9 9
Loss of Osseointegration 9 9
Material Separation 8 8
Compatibility Problem 8 8
Material Twisted/Bent 8 8
Failure to Osseointegrate 7 7
Positioning Failure 7 7
Failure to Align 7 7
Loose or Intermittent Connection 6 6
Unstable 6 6
Naturally Worn 5 5
Component Missing 5 5
Device Slipped 4 4
Material Deformation 4 4
Mechanics Altered 3 3
Noise, Audible 3 3
Difficult to Remove 3 3
Therapeutic or Diagnostic Output Failure 3 3
Material Disintegration 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 346 346
Neck Pain 230 230
Insufficient Information 220 220
No Clinical Signs, Symptoms or Conditions 164 164
Osteolysis 150 150
No Code Available 136 136
No Known Impact Or Consequence To Patient 122 122
Ossification 113 113
Failure of Implant 97 97
No Consequences Or Impact To Patient 91 91
No Information 62 62
Unspecified Infection 61 61
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 59 59
Numbness 45 45
Dysphagia/ Odynophagia 36 36
Patient Problem/Medical Problem 29 29
Inflammation 24 24
Loss of Range of Motion 23 23
Inadequate Pain Relief 23 23
Implant Pain 20 20
Stenosis 20 20
Hypersensitivity/Allergic reaction 19 19
Vertebral Fracture 17 17
Joint Laxity 17 17
Paralysis 17 17
Spinal Column Injury 17 17
Muscle Weakness 16 16
Nerve Damage 15 15
Bone Fracture(s) 15 15
Joint Disorder 13 13
Metal Related Pathology 12 12
Neuropathy 12 12
Fall 11 11
Foreign Body In Patient 10 10
Headache 9 9
Bacterial Infection 9 9
Unspecified Musculoskeletal problem 9 9
Unspecified Blood or Lymphatic problem 9 9
Discomfort 8 8
Ambulation Difficulties 8 8
Spinal Cord Injury 8 8
Neuralgia 8 8
Hemorrhage/Bleeding 7 7
Dysphasia 7 7
Rash 7 7
Paresis 7 7
Cramp(s) /Muscle Spasm(s) 7 7
Abscess 7 7
Peritonitis 6 6
Peripheral Nervous Injury 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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