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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device appliance, fixation, nail/blade/plate combination, single component
Regulation Description Single/multiple component metallic bone fixation appliances and accessories.
Product CodeKTW
Regulation Number 888.3030
Device Class 2

MDR Year MDR Reports MDR Events
2020 60 60
2021 25 25
2022 50 50
2023 30 30
2024 123 123
2025 39 39

Device Problems MDRs with this Device Problem Events in those MDRs
Break 144 144
Adverse Event Without Identified Device or Use Problem 76 76
Patient Device Interaction Problem 33 33
Failure to Cut 17 17
Device-Device Incompatibility 12 12
Material Twisted/Bent 8 8
Migration 8 8
Positioning Failure 7 7
Fracture 7 7
Material Deformation 6 6
Entrapment of Device 4 4
Physical Resistance/Sticking 4 4
Insufficient Information 3 3
Failure to Power Up 3 3
Defective Device 2 2
Operating System Becomes Nonfunctional 1 1
Crack 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Positioning Problem 1 1
Use of Device Problem 1 1
Device Damaged by Another Device 1 1
Difficult or Delayed Positioning 1 1
Detachment of Device or Device Component 1 1
No Apparent Adverse Event 1 1
Device Dislodged or Dislocated 1 1
Appropriate Term/Code Not Available 1 1
Loss of or Failure to Bond 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Failure of Implant 71 71
Insufficient Information 55 55
No Clinical Signs, Symptoms or Conditions 49 49
Pain 29 29
Malunion of Bone 27 27
Non-union Bone Fracture 26 26
Foreign Body In Patient 22 22
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 20 20
Hypersensitivity/Allergic reaction 14 14
Implant Pain 14 14
Unspecified Infection 9 9
Bone Fracture(s) 6 6
Loss of Range of Motion 6 6
No Code Available 5 5
Unspecified Tissue Injury 4 4
Arthritis 4 4
Impaired Healing 3 3
Necrosis 2 2
Nerve Damage 2 2
Osteolysis 2 2
Physical Asymmetry 2 2
Joint Dislocation 1 1
Seizures 1 1
Post Operative Wound Infection 1 1
Irritation 1 1
Seroma 1 1
Swelling 1 1
Fall 1 1
Reaction 1 1
Limb Fracture 1 1
Swelling/ Edema 1 1
No Consequences Or Impact To Patient 1 1
Ambulation Difficulties 1 1

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