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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device wire, surgical
Regulation Description Single/multiple component metallic bone fixation appliances and accessories.
Product CodeLRN
Regulation Number 888.3030
Device Class 2

MDR Year MDR Reports MDR Events
2020 68 68
2021 118 118
2022 106 106
2023 140 140
2024 87 87
2025 72 72

Device Problems MDRs with this Device Problem Events in those MDRs
Material Deformation 211 211
Break 168 168
Device-Device Incompatibility 102 102
Adverse Event Without Identified Device or Use Problem 91 91
Entrapment of Device 90 90
No Apparent Adverse Event 14 14
Migration 8 8
Device Slipped 5 5
Material Integrity Problem 4 4
Contamination /Decontamination Problem 4 4
Scratched Material 4 4
Defective Device 3 3
Appropriate Term/Code Not Available 3 3
Improper or Incorrect Procedure or Method 3 3
Difficult to Remove 2 2
Tear, Rip or Hole in Device Packaging 2 2
Disconnection 1 1
Activation, Positioning or Separation Problem 1 1
Mechanical Problem 1 1
Difficult to Advance 1 1
Unintended Movement 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Failure to Cut 1 1
Material Protrusion/Extrusion 1 1
Device Dislodged or Dislocated 1 1
Mechanical Jam 1 1
Biocompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 337 337
Foreign Body In Patient 90 90
Insufficient Information 35 35
No Code Available 25 25
Pain 23 23
No Consequences Or Impact To Patient 22 22
Non-union Bone Fracture 21 21
Unspecified Infection 18 18
Unspecified Tissue Injury 18 18
Post Operative Wound Infection 17 17
Injury 9 9
Hypersensitivity/Allergic reaction 7 7
Failure of Implant 7 7
Bone Fracture(s) 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Inflammation 5 5
Skin Inflammation/ Irritation 4 4
Wound Dehiscence 3 3
Hemorrhage/Bleeding 3 3
Necrosis 3 3
Swelling/ Edema 3 3
Foreign Body Reaction 3 3
Malunion of Bone 3 3
Ambulation Difficulties 2 2
Arthritis 2 2
Physical Asymmetry 2 2
Ulcer 2 2
No Patient Involvement 2 2
Nerve Damage 2 2
Needle Stick/Puncture 2 2
Muscular Rigidity 1 1
Discomfort 1 1
Erythema 1 1
Thrombosis/Thrombus 1 1
Abscess 1 1
Fever 1 1
No Known Impact Or Consequence To Patient 1 1
Joint Laxity 1 1
Cellulitis 1 1
Osteopenia/ Osteoporosis 1 1
Tissue Damage 1 1
Hematoma 1 1
Metal Related Pathology 1 1
Sepsis 1 1
Fatigue 1 1
Pressure Sores 1 1
Pneumothorax 1 1
Impaired Healing 1 1
Device Embedded In Tissue or Plaque 1 1

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