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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device orthosis, spondylolisthesis spinal fixation
Regulation Description Thoracolumbosacral pedicle screw system.
Product CodeMNH
Regulation Number 888.3070
Device Class 2

MDR Year MDR Reports MDR Events
2020 432 432
2021 543 543
2022 266 266
2023 122 122
2024 303 303
2025 49 49

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 604 604
Break 162 162
Migration 145 145
Loose or Intermittent Connection 106 106
Device Slipped 74 74
No Apparent Adverse Event 62 62
Insufficient Information 52 52
Unintended Movement 52 52
Appropriate Term/Code Not Available 51 51
Fracture 48 48
Material Integrity Problem 45 45
Device-Device Incompatibility 45 45
Patient Device Interaction Problem 39 39
Loosening of Implant Not Related to Bone-Ingrowth 37 37
Material Twisted/Bent 33 33
Detachment of Device or Device Component 32 32
Migration or Expulsion of Device 31 31
Material Deformation 30 30
Device Dislodged or Dislocated 27 27
Human-Device Interface Problem 19 19
Use of Device Problem 19 19
Material Separation 19 19
Mechanical Problem 17 17
Compatibility Problem 12 12
Fluid/Blood Leak 11 11
Entrapment of Device 11 11
Physical Resistance/Sticking 9 9
Material Fragmentation 8 8
Product Quality Problem 8 8
Improper Chemical Reaction 5 5
Device Handling Problem 5 5
Difficult to Advance 4 4
Difficult to Remove 4 4
Mechanics Altered 4 4
Noise, Audible 3 3
Loss of or Failure to Bond 3 3
Improper or Incorrect Procedure or Method 3 3
Activation, Positioning or Separation Problem 3 3
Inaccurate Information 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Mechanical Jam 2 2
Material Protrusion/Extrusion 2 2
Positioning Failure 2 2
Positioning Problem 2 2
Malposition of Device 2 2
Output Problem 2 2
Inflation Problem 1 1
Component Missing 1 1
Difficult to Insert 1 1
Expulsion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 345 345
No Clinical Signs, Symptoms or Conditions 285 285
Pain 201 201
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 173 173
No Code Available 155 155
Failure of Implant 142 142
Non-union Bone Fracture 94 94
Injury 70 70
Post Operative Wound Infection 68 68
Bone Fracture(s) 67 67
Unspecified Infection 65 65
Nerve Damage 62 62
Osteolysis 60 60
Unspecified Tissue Injury 53 53
Spinal Column Injury 53 53
No Consequences Or Impact To Patient 51 51
Hematoma 44 44
Neurological Deficit/Dysfunction 39 39
Spinal Cord Injury 30 30
Cerebrospinal Fluid Leakage 29 29
Dysphagia/ Odynophagia 26 26
Hypoesthesia 23 23
Physical Asymmetry 22 22
Unspecified Nervous System Problem 19 19
Paralysis 19 19
Joint Laxity 17 17
Death 16 16
Foreign Body In Patient 14 14
Impaired Healing 13 13
No Patient Involvement 12 12
Perforation of Vessels 11 11
Hemorrhage/Bleeding 10 10
No Known Impact Or Consequence To Patient 10 10
Deformity/ Disfigurement 9 9
Discomfort 9 9
Neck Pain 9 9
Fall 8 8
Numbness 8 8
Decreased Sensitivity 8 8
Thromboembolism 8 8
Fatigue 7 7
Wound Dehiscence 7 7
Loss of Range of Motion 6 6
Implant Pain 6 6
Stenosis 5 5
Tissue Damage 5 5
Muscular Rigidity 5 5
Hypersensitivity/Allergic reaction 4 4
Speech Disorder 3 3
Device Embedded In Tissue or Plaque 3 3

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