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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 33
2024 123 123
2025 88 88

Device Problems MDRs with this Device Problem Events in those MDRs
Break 162 164
Adverse Event Without Identified Device or Use Problem 77 77
Patient Device Interaction Problem 48 48
Failure to Cut 20 21
Positioning Failure 13 13
Device-Device Incompatibility 12 12
Material Twisted/Bent 12 12
Migration 9 9
Entrapment of Device 7 7
Fracture 7 7
Material Deformation 6 6
Physical Resistance/Sticking 4 4
Fitting Problem 3 3
Insufficient Information 3 3
Failure to Power Up 3 3
Defective Device 2 2
Use of Device Problem 2 2
No Apparent Adverse Event 2 2
Operating System Becomes Nonfunctional 1 1
Crack 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Positioning 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
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
No Clinical Signs, Symptoms or Conditions 75 78
Failure of Implant 71 71
Insufficient Information 57 57
Pain 45 45
Non-union Bone Fracture 41 41
Foreign Body In Patient 28 28
Malunion of Bone 27 27
Unspecified Infection 24 24
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 20 20
Hypersensitivity/Allergic reaction 14 14
Implant Pain 14 14
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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