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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
Product CodeJDP
Regulation Number 888.3030
Device Class 2

MDR Year MDR Reports MDR Events
2019 49 49
2020 56 56
2021 79 79
2022 61 61
2023 29 29
2024 19 19

Device Problems MDRs with this Device Problem Events in those MDRs
Break 103 103
Adverse Event Without Identified Device or Use Problem 102 102
Device-Device Incompatibility 59 59
Material Twisted/Bent 14 14
Device Slipped 7 7
Migration 7 7
Material Deformation 7 7
No Apparent Adverse Event 4 4
Use of Device Problem 3 3
Packaging Problem 3 3
Crack 2 2
Fitting Problem 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Detachment of Device or Device Component 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Non-union Bone Fracture 73 73
No Code Available 69 69
No Clinical Signs, Symptoms or Conditions 55 55
Pain 35 35
Unspecified Infection 29 29
Failure of Implant 22 22
Bone Fracture(s) 22 22
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 21 21
Insufficient Information 16 16
Malunion of Bone 12 12
No Consequences Or Impact To Patient 8 8
No Patient Involvement 4 4
Arthritis 4 4
Injury 3 3
Unspecified Tissue Injury 3 3
Impaired Healing 2 2
Joint Dislocation 2 2
Thrombosis/Thrombus 2 2
Osteolysis 2 2
Discomfort 2 2
Fall 2 2
Calcium Deposits/Calcification 2 2
Swelling/ Edema 2 2
Physical Asymmetry 2 2
Ambulation Difficulties 2 2
Not Applicable 1 1
Inflammation 1 1
Local Reaction 1 1
Nerve Damage 1 1
Loss of Range of Motion 1 1
Reaction 1 1
Limb Fracture 1 1
Deformity/ Disfigurement 1 1

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