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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 88 88
2025 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Material Deformation 179 179
Break 145 145
Device-Device Incompatibility 98 98
Adverse Event Without Identified Device or Use Problem 85 85
Entrapment of Device 75 75
No Apparent Adverse Event 13 13
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 292 292
Foreign Body In Patient 77 77
Insufficient Information 31 31
No Code Available 25 25
No Consequences Or Impact To Patient 22 22
Pain 22 22
Non-union Bone Fracture 19 19
Unspecified Tissue Injury 18 18
Unspecified Infection 17 17
Post Operative Wound Infection 17 17
Injury 9 9
Failure of Implant 7 7
Bone Fracture(s) 7 7
Hypersensitivity/Allergic reaction 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Inflammation 5 5
Hemorrhage/Bleeding 3 3
Swelling/ Edema 3 3
Foreign Body Reaction 3 3
Skin Inflammation/ Irritation 3 3
Necrosis 3 3
Wound Dehiscence 3 3
Needle Stick/Puncture 2 2
Nerve Damage 2 2
No Patient Involvement 2 2
Malunion of Bone 2 2
Ulcer 2 2
Arthritis 2 2
Ambulation Difficulties 2 2
Cellulitis 1 1
No Known Impact Or Consequence To Patient 1 1
Osteopenia/ Osteoporosis 1 1
Hematoma 1 1
Erythema 1 1
Discomfort 1 1
Abscess 1 1
Metal Related Pathology 1 1
Joint Laxity 1 1
Sepsis 1 1
Pneumothorax 1 1
Tissue Damage 1 1
Physical Asymmetry 1 1
Impaired Healing 1 1
Pressure Sores 1 1
Device Embedded In Tissue or Plaque 1 1

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