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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
2021 25 25
2022 50 50
2023 30 33
2024 123 123
2025 96 96

Device Problems MDRs with this Device Problem Events in those MDRs
Break 130 132
Adverse Event Without Identified Device or Use Problem 74 74
Patient Device Interaction Problem 48 48
Failure to Cut 20 21
Positioning Failure 14 14
Entrapment of Device 12 12
Device-Device Incompatibility 9 9
Migration 9 9
Material Deformation 6 6
Material Twisted/Bent 5 5
Physical Resistance/Sticking 4 4
Fitting Problem 3 3
Insufficient Information 2 2
Defective Device 2 2
Use of Device Problem 2 2
No Apparent Adverse Event 2 2
Fracture 2 2
Manufacturing, Packaging or Shipping Problem 1 1
Device Damaged by Another Device 1 1
Difficult or Delayed Positioning 1 1
Detachment of Device or Device Component 1 1
Failure to Advance 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 74 77
Failure of Implant 54 54
Pain 38 38
Insufficient Information 35 35
Non-union Bone Fracture 34 34
Foreign Body In Patient 33 33
Malunion of Bone 25 25
Unspecified Infection 23 23
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 19 19
Hypersensitivity/Allergic reaction 14 14
Implant Pain 14 14
Loss of Range of Motion 6 6
Bone Fracture(s) 5 5
Unspecified Tissue Injury 4 4
Arthritis 4 4
Necrosis 2 2
Nerve Damage 2 2
Osteolysis 2 2
Physical Asymmetry 2 2
Joint Dislocation 1 1
Post Operative Wound Infection 1 1
Seroma 1 1
Limb Fracture 1 1

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