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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 285 285

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 775 775
Break 218 218
Migration 152 152
No Apparent Adverse Event 128 128
Loose or Intermittent Connection 106 106
Device Slipped 93 93
Unintended Movement 64 64
Insufficient Information 64 64
Appropriate Term/Code Not Available 53 53
Device-Device Incompatibility 47 47
Patient Device Interaction Problem 46 46
Material Integrity Problem 44 44
Loosening of Implant Not Related to Bone-Ingrowth 39 39
Fracture 38 38
Detachment of Device or Device Component 37 37
Material Twisted/Bent 33 33
Migration or Expulsion of Device 33 33
Material Deformation 28 28
Device Dislodged or Dislocated 27 27
Mechanical Problem 20 20
Use of Device Problem 19 19
Material Separation 18 18
Human-Device Interface Problem 18 18
Compatibility Problem 12 12
Entrapment of Device 11 11
Physical Resistance/Sticking 9 9
Fluid/Blood Leak 9 9
Material Fragmentation 8 8
Product Quality Problem 8 8
Improper or Incorrect Procedure or Method 5 5
Device Handling Problem 5 5
Corroded 4 4
Mechanical Jam 4 4
Difficult to Advance 4 4
Difficult to Remove 4 4
Improper Chemical Reaction 4 4
Mechanics Altered 4 4
Noise, Audible 3 3
Inaccurate Information 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Activation, Positioning or Separation Problem 3 3
Loss of or Failure to Bond 2 2
Malposition of Device 2 2
Output Problem 2 2
Patient-Device Incompatibility 2 2
Positioning Problem 2 2
Positioning Failure 2 2
Crack 2 2
Material Protrusion/Extrusion 2 2
Display or Visual Feedback Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 402 402
Insufficient Information 327 327
No Clinical Signs, Symptoms or Conditions 267 267
Pain 259 259
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 173 173
Failure of Implant 159 159
Non-union Bone Fracture 127 127
Unspecified Infection 104 104
Bone Fracture(s) 88 88
Nerve Damage 86 86
Injury 74 74
Neurological Deficit/Dysfunction 70 70
Post Operative Wound Infection 68 68
Osteolysis 64 64
No Consequences Or Impact To Patient 61 61
Unspecified Tissue Injury 53 53
Hematoma 49 49
Spinal Column Injury 44 44
Cerebrospinal Fluid Leakage 36 36
Paralysis 31 31
Spinal Cord Injury 31 31
Hypoesthesia 30 30
Unspecified Nervous System Problem 30 30
Dysphagia/ Odynophagia 29 29
Impaired Healing 26 26
No Known Impact Or Consequence To Patient 23 23
Physical Asymmetry 22 22
Joint Laxity 18 18
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
Stenosis 9 9
Deformity/ Disfigurement 9 9
Neck Pain 9 9
Wound Dehiscence 9 9
Seroma 9 9
Fall 8 8
Numbness 8 8
Loss of Range of Motion 8 8
Thromboembolism 8 8
Decreased Sensitivity 8 8
Fatigue 7 7
Necrosis 7 7
Tissue Damage 6 6
Weakness 6 6
Inflammation 6 6
Implant Pain 6 6

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