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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 261 261

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 770 770
Break 216 216
Migration 146 146
No Apparent Adverse Event 128 128
Loose or Intermittent Connection 105 105
Device Slipped 92 92
Unintended Movement 64 64
Insufficient Information 61 61
Appropriate Term/Code Not Available 53 53
Device-Device Incompatibility 47 47
Patient Device Interaction Problem 45 45
Material Integrity Problem 43 43
Fracture 38 38
Detachment of Device or Device Component 37 37
Loosening of Implant Not Related to Bone-Ingrowth 37 37
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 311 311
No Clinical Signs, Symptoms or Conditions 265 265
Pain 258 258
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 172 172
Failure of Implant 159 159
Non-union Bone Fracture 126 126
Unspecified Infection 103 103
Bone Fracture(s) 87 87
Nerve Damage 86 86
Injury 74 74
Neurological Deficit/Dysfunction 70 70
Post Operative Wound Infection 68 68
Osteolysis 63 63
No Consequences Or Impact To Patient 61 61
Unspecified Tissue Injury 53 53
Hematoma 49 49
Spinal Column Injury 42 42
Cerebrospinal Fluid Leakage 36 36
Paralysis 31 31
Spinal Cord Injury 31 31
Hypoesthesia 30 30
Dysphagia/ Odynophagia 29 29
Unspecified Nervous System Problem 29 29
Impaired Healing 26 26
No Known Impact Or Consequence To Patient 23 23
Physical Asymmetry 22 22
Joint Laxity 17 17
No Patient Involvement 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
Deformity/ Disfigurement 9 9
Neck Pain 9 9
Decreased Sensitivity 8 8
Thromboembolism 8 8
Numbness 8 8
Loss of Range of Motion 8 8
Fall 8 8
Fatigue 7 7
Necrosis 7 7
Inflammation 6 6
Weakness 6 6
Thrombosis 6 6
Tissue Damage 6 6
Implant Pain 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
Speech Disorder 3 3
Device Embedded In Tissue or Plaque 3 3
Blood Loss 3 3
Swelling/ Edema 3 3
Metal Related Pathology 3 3
Incontinence 3 3
Skin Irritation 3 3
Urinary Tract Infection 2 2
Depression 2 2
Reaction 2 2
Paresis 2 2
Pneumonia 2 2
Nausea 2 2
Stroke/CVA 2 2
Headache 2 2
Bacterial Infection 2 2
Pulmonary Embolism 2 2
Unspecified Musculoskeletal problem 2 2
Ambulation Difficulties 2 2
Pseudoaneurysm 2 2
Inadequate Osseointegration 2 2
Unspecified Kidney or Urinary Problem 2 2
Vertebral Fracture 2 2
Intervertebral Disc Compression or Protrusion 2 2
Malunion of Bone 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Paresthesia 1 1
Fibrosis 1 1
Constipation 1 1
Neuralgia 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Heart Failure/Congestive Heart Failure 1 1
Renal Impairment 1 1
Confusion/ Disorientation 1 1
Abdominal Distention 1 1
Respiratory Failure 1 1
Sleep Dysfunction 1 1
Skin Inflammation/ Irritation 1 1
Subcutaneous Nodule 1 1
Purulent Discharge 1 1
Fever 1 1
Erosion 1 1
Calcium Deposits/Calcification 1 1

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