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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 61
2023 29 29
2024 30 30
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 90 90
Adverse Event Without Identified Device or Use Problem 89 89
Device-Device Incompatibility 55 55
Material Twisted/Bent 13 13
Device Slipped 7 7
Material Deformation 5 5
Migration 5 5
Packaging Problem 3 3
Use of Device Problem 2 2
Fitting Problem 1 1
Detachment of Device or Device Component 1 1
Crack 1 1
Insufficient Information 1 1
No Apparent Adverse Event 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Non-union Bone Fracture 64 64
No Clinical Signs, Symptoms or Conditions 55 55
No Code Available 36 36
Pain 31 31
Unspecified Infection 27 27
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 21 21
Insufficient Information 21 21
Failure of Implant 17 17
Bone Fracture(s) 15 15
Malunion of Bone 12 12
No Consequences Or Impact To Patient 6 6
Fall 3 3
Unspecified Tissue Injury 3 3
No Patient Involvement 2 2
Loss of Range of Motion 2 2
Ambulation Difficulties 2 2
Swelling/ Edema 2 2
Injury 2 2
Thrombosis/Thrombus 2 2
Physical Asymmetry 2 2
Local Reaction 1 1
Limb Fracture 1 1
Arthritis 1 1
Erythema 1 1
Not Applicable 1 1
Impaired Healing 1 1
Necrosis 1 1
Deformity/ Disfigurement 1 1
Nerve Damage 1 1
Reaction 1 1

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