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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
2019 403 403
2020 442 442
2021 543 543
2022 266 266
2023 122 122
2024 228 228

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 757 757
Break 216 216
Migration 134 134
No Apparent Adverse Event 127 127
Loose or Intermittent Connection 105 105
Device Slipped 91 91
Unintended Movement 64 64
Insufficient Information 53 53
Appropriate Term/Code Not Available 52 52
Device-Device Incompatibility 47 47
Patient Device Interaction Problem 44 44
Material Integrity Problem 43 43
Detachment of Device or Device Component 37 37
Loosening of Implant Not Related to Bone-Ingrowth 37 37
Fracture 36 36
Migration or Expulsion of Device 33 33
Material Twisted/Bent 30 30
Material Deformation 27 27
Device Dislodged or Dislocated 27 27
Mechanical Problem 20 20
Use of Device Problem 19 19
Material Separation 17 17
Human-Device Interface Problem 17 17
Compatibility Problem 12 12
Entrapment of Device 11 11
Physical Resistance/Sticking 9 9
Fluid/Blood Leak 8 8
Material Fragmentation 8 8
Product Quality Problem 8 8
Improper or Incorrect Procedure or Method 5 5
Device Handling Problem 5 5
Mechanical Jam 4 4
Mechanics Altered 4 4
Difficult to Remove 4 4
Difficult to Advance 4 4
Corroded 4 4
Activation, Positioning or Separation Problem 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Improper Chemical Reaction 3 3
Noise, Audible 3 3
Inaccurate Information 3 3
Material Protrusion/Extrusion 2 2
Output Problem 2 2
Positioning Problem 2 2
Malposition of Device 2 2
Patient-Device Incompatibility 2 2
Loss of or Failure to Bond 2 2
Crack 2 2
Positioning Failure 2 2
Display or Visual Feedback Problem 1 1
Collapse 1 1
Inflation Problem 1 1
Difficult to Insert 1 1
Off-Label Use 1 1
Device Appears to Trigger Rejection 1 1
Defective Component 1 1
Component Missing 1 1
Defective Device 1 1
Deformation Due to Compressive Stress 1 1
Connection Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Osseointegration Problem 1 1
Expulsion 1 1
Wrong Label 1 1
Failure to Eject 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 402 402
Insufficient Information 293 293
No Clinical Signs, Symptoms or Conditions 263 263
Pain 251 251
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 172 172
Failure of Implant 159 159
Non-union Bone Fracture 120 120
Unspecified Infection 100 100
Bone Fracture(s) 83 83
Nerve Damage 81 81
Injury 74 74
Neurological Deficit/Dysfunction 70 70
Post Operative Wound Infection 68 68
No Consequences Or Impact To Patient 61 61
Osteolysis 60 60
Unspecified Tissue Injury 50 50
Hematoma 46 46
Spinal Column Injury 39 39
Paralysis 31 31
Cerebrospinal Fluid Leakage 31 31
Hypoesthesia 30 30
Dysphagia/ Odynophagia 26 26
Spinal Cord Injury 26 26
Unspecified Nervous System Problem 26 26
No Known Impact Or Consequence To Patient 23 23
Impaired Healing 23 23
Physical Asymmetry 22 22
No Patient Involvement 17 17
Death 16 16
Joint Laxity 15 15
Foreign Body In Patient 14 14
Discomfort 12 12
Perforation of Vessels 11 11
Hemorrhage/Bleeding 10 10
Wound Dehiscence 9 9
Seroma 9 9
Stenosis 9 9
Neck Pain 9 9
Deformity/ Disfigurement 8 8
Numbness 8 8
Fall 8 8
Fatigue 7 7
Necrosis 7 7
Loss of Range of Motion 6 6
Weakness 6 6
Thrombosis 6 6
Tissue Damage 6 6
Decreased Sensitivity 6 6
Implant Pain 6 6
Thromboembolism 5 5
Muscular Rigidity 5 5
Hypersensitivity/Allergic reaction 5 5
Inflammation 5 5
Ossification 4 4
Abscess 4 4
Limited Mobility Of The Implanted Joint 4 4
No Information 4 4
Metal Related Pathology 3 3
Device Embedded In Tissue or Plaque 3 3
Blood Loss 3 3
Swelling/ Edema 3 3
Incontinence 3 3
Skin Irritation 3 3
Paresis 2 2
Pneumonia 2 2
Urinary Tract Infection 2 2
Reaction 2 2
Nausea 2 2
Stroke/CVA 2 2
Headache 2 2
Bacterial Infection 2 2
Pulmonary Embolism 2 2
Intervertebral Disc Compression or Protrusion 2 2
Pseudoaneurysm 2 2
Inadequate Osseointegration 2 2
Unspecified Musculoskeletal problem 2 2
Skin Inflammation/ Irritation 1 1
Subcutaneous Nodule 1 1
Malunion of Bone 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Heart Failure/Congestive Heart Failure 1 1
Renal Impairment 1 1
Unspecified Kidney or Urinary Problem 1 1
Vertebral Fracture 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Constipation 1 1
Neuralgia 1 1
Speech Disorder 1 1
Paresthesia 1 1
Fibrosis 1 1
Abdominal Distention 1 1
Respiratory Failure 1 1
Sleep Dysfunction 1 1
Ambulation Difficulties 1 1
Purulent Discharge 1 1
Fever 1 1
Erosion 1 1
Calcium Deposits/Calcification 1 1
Cellulitis 1 1
Adhesion(s) 1 1

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