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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 10 10

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
No Apparent Adverse Event 2 2
Use of Device Problem 2 2
Insufficient Device Problem Information 1 1
Detachment of Device or Device Component 1 1
Material Integrity Problem 1 1
Fitting Problem 1 1
Crack 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 91 92
Nonunion/Delayed-union Bone Fracture 59 59
Insufficient Information 35 35
Pain 24 25
Appropriate Clinical Signs, Symptoms and 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
Swelling/ Edema 3 3
Unspecified Tissue Injury 3 3
Fall 3 4
Loss of Range of Motion 2 2
Physical Asymmetry 2 2
Thrombosis/Thrombus 2 2
Necrosis 1 1
Limb Fracture 1 2
Nerve Damage 1 2
Arthritis 1 2
Local Reaction 1 1
Deformity/ Disfigurement 1 1
Erythema 1 1
Ambulation or Postural Difficulties 1 1

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