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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
Product CodeMNH
Regulation Number 888.3070
Device Class 2

MDR Year MDR Reports MDR Events
2018 129 129
2019 403 403
2020 442 442
2021 543 543
2022 265 265
2023 89 89

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 745 745
Break 240 240
No Apparent Adverse Event 124 124
Loose or Intermittent Connection 112 112
Migration 110 110
Device Slipped 84 84
Unintended Movement 64 64
Appropriate Term/Code Not Available 52 52
Device-Device Incompatibility 52 52
Loosening of Implant Not Related to Bone-Ingrowth 40 40
Patient Device Interaction Problem 39 39
Material Integrity Problem 39 39
Migration or Expulsion of Device 37 37
Fracture 34 34
Material Twisted/Bent 32 32
Material Deformation 30 30
Detachment of Device or Device Component 23 23
Insufficient Information 21 21
Device Dislodged or Dislocated 19 19
Mechanical Problem 16 16
Material Separation 15 15
Compatibility Problem 14 14
Entrapment of Device 11 11
Physical Resistance/Sticking 7 7
Material Split, Cut or Torn 5 5
Mechanical Jam 5 5
Fluid/Blood Leak 5 5
Fitting Problem 5 5
Difficult to Advance 4 4
Corroded 4 4
Difficult to Remove 4 4
Mechanics Altered 4 4
Material Protrusion/Extrusion 4 4
Positioning Problem 4 4
Activation, Positioning or Separation Problem 3 3
Inaccurate Information 3 3
Noise, Audible 3 3
Component Missing 3 3
Improper or Incorrect Procedure or Method 2 2
Improper Chemical Reaction 2 2
Malposition of Device 2 2
Patient-Device Incompatibility 2 2
Crack 2 2
Positioning Failure 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Output Problem 2 2
Therapeutic or Diagnostic Output Failure 1 1
Torn Material 1 1
Osseointegration Problem 1 1
Failure to Eject 1 1
Disconnection 1 1
Display or Visual Feedback Problem 1 1
Collapse 1 1
Detachment Of Device Component 1 1
Partial Blockage 1 1
Device Appears to Trigger Rejection 1 1
Material Fragmentation 1 1
Inflation Problem 1 1
Connection Problem 1 1
Device Damaged by Another Device 1 1
Device Inoperable 1 1
Structural Problem 1 1
Defective Device 1 1
Defective Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 440 440
Pain 258 258
No Clinical Signs, Symptoms or Conditions 246 246
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 170 170
Failure of Implant 148 148
Insufficient Information 131 131
Non-union Bone Fracture 120 120
Unspecified Infection 110 110
Bone Fracture(s) 80 80
Injury 79 79
No Consequences Or Impact To Patient 75 75
Neurological Deficit/Dysfunction 70 70
No Known Impact Or Consequence To Patient 69 69
Nerve Damage 68 68
Post Operative Wound Infection 65 65
Osteolysis 44 44
Unspecified Tissue Injury 43 43
Hematoma 42 42
Paralysis 31 31
Cerebrospinal Fluid Leakage 30 30
Hypoesthesia 30 30
Dysphagia/ Odynophagia 24 24
Unspecified Nervous System Problem 24 24
Physical Asymmetry 22 22
Impaired Healing 21 21
Spinal Cord Injury 21 21
No Patient Involvement 17 17
Death 16 16
Foreign Body In Patient 13 13
Discomfort 12 12
Perforation of Vessels 10 10
Hemorrhage/Bleeding 10 10
Wound Dehiscence 9 9
Seroma 9 9
Spinal Column Injury 8 8
Deformity/ Disfigurement 8 8
Stenosis 8 8
Neck Pain 7 7
Necrosis 7 7
Fall 7 7
Numbness 7 7
No Information 7 7
Loss of Range of Motion 6 6
Weakness 6 6
Thrombosis 6 6
Tissue Damage 6 6
Fatigue 5 5
Hypersensitivity/Allergic reaction 5 5
Inflammation 5 5
Muscular Rigidity 5 5
Joint Laxity 5 5
Limited Mobility Of The Implanted Joint 4 4
Incontinence 4 4
Ossification 4 4
Abscess 4 4
Skin Irritation 3 3
Decreased Sensitivity 3 3
Device Embedded In Tissue or Plaque 3 3
Blood Loss 3 3
Metal Related Pathology 3 3
Swelling/ Edema 3 3
Unspecified Musculoskeletal problem 2 2
Intervertebral Disc Compression or Protrusion 2 2
Implant Pain 2 2
Inadequate Osseointegration 2 2
Thromboembolism 2 2
Ambulation Difficulties 2 2
Pseudoaneurysm 2 2
Urinary Tract Infection 2 2
Burning Sensation 2 2
Tingling 2 2
Swelling 2 2
Reaction 2 2
Bacterial Infection 2 2
Pulmonary Embolism 2 2
Headache 2 2
Nausea 2 2
Stroke/CVA 2 2
Itching Sensation 2 2
Paresis 2 2
Pneumonia 2 2
Irritation 1 1
Purulent Discharge 1 1
Fever 1 1
Erosion 1 1
Bruise/Contusion 1 1
Calcium Deposits/Calcification 1 1
Cellulitis 1 1
Adhesion(s) 1 1
Anemia 1 1
Arthritis 1 1
Complaint, Ill-Defined 1 1
Pressure Sores 1 1
Rupture 1 1
Hernia 1 1
Depression 1 1
Skin Erosion 1 1
Cramp(s) 1 1
Urinary Retention 1 1
Fibrosis 1 1

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