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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
2020 56 56
2021 79 79
2022 61 77
2023 29 31
2024 30 30
2025 39 39

Device Problems MDRs with this Device Problem Events in those MDRs
Break 97 113
Adverse Event Without Identified Device or Use Problem 90 91
Device-Device Incompatibility 82 83
Material Twisted/Bent 24 24
Device Slipped 7 7
Material Deformation 5 5
Migration 5 6
Packaging Problem 3 3
Use of Device Problem 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
No Apparent Adverse Event 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 85 86
Non-union Bone Fracture 65 65
No Code Available 36 36
Pain 32 33
Unspecified Infection 29 29
Insufficient Information 29 29
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 21 36
Failure of Implant 17 17
Bone Fracture(s) 15 16
Malunion of Bone 12 12
No Consequences Or Impact To Patient 6 6
Fall 3 4
Unspecified Tissue Injury 3 3
Injury 2 2
Thrombosis/Thrombus 2 2
No Patient Involvement 2 2
Loss of Range of Motion 2 2
Swelling/ Edema 2 2
Physical Asymmetry 2 2
Ambulation Difficulties 2 2
Impaired Healing 1 1
Not Applicable 1 1
Necrosis 1 1
Local Reaction 1 1
Nerve Damage 1 2
Erythema 1 1
Reaction 1 1
Limb Fracture 1 2
Deformity/ Disfigurement 1 1
Arthritis 1 2

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