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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
2021 531 534
2022 265 267
2023 121 124
2024 300 301
2025 91 91
2026 38 38

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 447 452
Migration 129 131
Break 122 122
Loose or Intermittent Connection 92 92
Device Slipped 54 54
Fracture 53 53
Material Integrity Problem 51 53
Insufficient Information 50 52
Appropriate Term/Code Not Available 44 45
Device-Device Incompatibility 32 32
Patient Device Interaction Problem 31 31
Loosening of Implant Not Related to Bone-Ingrowth 30 30
Material Deformation 29 29
Detachment of Device or Device Component 29 29
Material Twisted/Bent 27 27
Device Dislodged or Dislocated 22 22
Human-Device Interface Problem 22 22
Use of Device Problem 19 19
Mechanical Problem 17 17
Migration or Expulsion of Device 13 13
Material Separation 12 12
Fluid/Blood Leak 11 11
Failure to Osseointegrate 10 10
Entrapment of Device 10 10
Compatibility Problem 10 10
No Apparent Adverse Event 9 9
Physical Resistance/Sticking 8 8
Product Quality Problem 8 8
Material Fragmentation 7 7
Unintended Movement 7 7
Device Handling Problem 5 5
Improper Chemical Reaction 5 5
Difficult to Remove 4 4
Loss of or Failure to Bond 3 3
Improper or Incorrect Procedure or Method 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Inaccurate Information 3 3
Mechanical Jam 2 2
Output Problem 2 2
Positioning Problem 2 2
Activation, Positioning or Separation Problem 2 2
Positioning Failure 2 2
Display or Visual Feedback Problem 1 1
Collapse 1 1
Crack 1 1
Inflation Problem 1 1
Difficult to Insert 1 1
Off-Label Use 1 1
Expulsion 1 1
Defective Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 332 336
No Clinical Signs, Symptoms or Conditions 268 271
Pain 162 164
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 158 159
Failure of Implant 96 96
Non-union Bone Fracture 78 81
Post Operative Wound Infection 63 65
Osteolysis 61 63
Spinal Column Injury 58 58
Unspecified Tissue Injury 48 50
Nerve Damage 43 46
Unspecified Infection 38 39
Hematoma 33 34
Spinal Cord Injury 27 29
Bone Fracture(s) 23 25
Physical Asymmetry 22 22
Cerebrospinal Fluid Leakage 20 21
Dysphagia/ Odynophagia 18 18
Joint Laxity 16 17
Foreign Body In Patient 14 14
Inadequate Osseointegration 12 12
Perforation of Vessels 12 12
Hemorrhage/Bleeding 10 10
Numbness 10 11
Impaired Healing 10 11
Fatigue 9 10
Neck Pain 9 11
Discomfort 9 9
Thromboembolism 8 10
Unspecified Nervous System Problem 7 7
Decreased Sensitivity 7 8
Loss of Range of Motion 6 7
Fall 6 7
Deformity/ Disfigurement 5 5
Implant Pain 5 5
Muscular Rigidity 5 5
Metal Related Pathology 4 4
Stenosis 4 5
Nicks, cuts or tears of dura or other tissues by device 3 3
Unspecified Musculoskeletal problem 3 3
Swelling/ Edema 3 3
Speech Disorder 3 3
Hypersensitivity/Allergic reaction 3 3
Abscess 3 3
Wound Dehiscence 3 3
Urinary Tract Infection 2 2
No Consequences Or Impact To Patient 2 2
Bacterial Infection 2 2
Intervertebral Disc Compression or Protrusion 2 2
Device Embedded In Tissue or Plaque 2 2

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