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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 239 239

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 760 760
Break 216 216
Migration 140 140
No Apparent Adverse Event 128 128
Loose or Intermittent Connection 105 105
Device Slipped 91 91
Unintended Movement 64 64
Insufficient Information 57 57
Appropriate Term/Code Not Available 53 53
Device-Device Incompatibility 47 47
Patient Device Interaction Problem 45 45
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 31 31
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
Improper Chemical Reaction 4 4
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
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 300 300
No Clinical Signs, Symptoms or Conditions 265 265
Pain 252 252
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 172 172
Failure of Implant 159 159
Non-union Bone Fracture 122 122
Unspecified Infection 101 101
Bone Fracture(s) 85 85
Nerve Damage 81 81
Injury 74 74
Neurological Deficit/Dysfunction 70 70
Post Operative Wound Infection 68 68
Osteolysis 62 62
No Consequences Or Impact To Patient 61 61
Unspecified Tissue Injury 53 53
Hematoma 46 46
Spinal Column Injury 41 41
Paralysis 31 31
Cerebrospinal Fluid Leakage 31 31
Hypoesthesia 30 30
Spinal Cord Injury 27 27
Unspecified Nervous System Problem 26 26
Dysphagia/ Odynophagia 26 26
Impaired Healing 25 25
No Known Impact Or Consequence To Patient 23 23
Physical Asymmetry 22 22
No Patient Involvement 17 17
Joint Laxity 17 17
Death 16 16
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 7 7
Thromboembolism 7 7
Decreased Sensitivity 7 7
Implant Pain 6 6
Weakness 6 6
Thrombosis 6 6
Tissue Damage 6 6
Inflammation 6 6
Hypersensitivity/Allergic reaction 5 5
Muscular Rigidity 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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