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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device condylar plate fixation implant
Regulation Description Single/multiple component metallic bone fixation appliances and accessories.
Product CodeJDP
Regulation Number 888.3030
Device Class 2

MDR Year MDR Reports MDR Events
2021 79 79
2022 61 77
2023 29 31
2024 30 30
2025 44 44
2026 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Break 83 99
Adverse Event Without Identified Device or Use Problem 82 83
Device-Device Incompatibility 65 66
Material Twisted/Bent 25 25
Material Deformation 4 4
Migration 3 4
Use of Device Problem 2 2
No Apparent Adverse Event 2 2
Fitting Problem 1 1
Crack 1 1
Insufficient Information 1 1
Material Integrity Problem 1 1
Detachment of Device or Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 91 92
Non-union Bone Fracture 59 59
Insufficient Information 34 34
Pain 24 25
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 20 35
Unspecified Infection 19 19
Malunion of Bone 12 12
Bone Fracture(s) 9 10
Failure of Implant 8 8
Fall 3 4
Unspecified Tissue Injury 3 3
Swelling/ Edema 3 3
Thrombosis/Thrombus 2 2
Loss of Range of Motion 2 2
Physical Asymmetry 2 2
Necrosis 1 1
Local Reaction 1 1
Erythema 1 1
Nerve Damage 1 2
Limb Fracture 1 2
Deformity/ Disfigurement 1 1
Arthritis 1 2
Ambulation Difficulties 1 1

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