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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


Premarket Reviews
ManufacturerDecision
DEPUY SYNTHES
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 117 117
2017 46 46
2018 56 56
2019 49 49
2020 56 56
2021 26 26

Device Problems MDRs with this Device Problem Events in those MDRs
Break 139 139
Adverse Event Without Identified Device or Use Problem 117 117
Device-Device Incompatibility 33 33
Unintended Movement 21 21
Migration or Expulsion of Device 8 8
Device Slipped 7 7
Detachment of Device or Device Component 7 7
Material Deformation 6 6
Migration 5 5
Bent 5 5
Packaging Problem 3 3
No Apparent Adverse Event 3 3
Insufficient Information 3 3
Crack 3 3
Appropriate Term/Code Not Available 2 2
Material Twisted/Bent 2 2
Corroded 2 2
Failure To Adhere Or Bond 1 1
Device Contamination with Chemical or Other Material 1 1
Material Integrity Problem 1 1
Operating System Becomes Nonfunctional 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Mechanical Problem 1 1
Difficult To Position 1 1
Device Operates Differently Than Expected 1 1
Use of Device Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 139 139
Failure of Implant 108 108
Non-union Bone Fracture 87 87
Unspecified Infection 46 46
Pain 45 45
Impaired Healing 26 26
Bone Fracture(s) 18 18
No Clinical Signs, Symptoms or Conditions 14 14
No Consequences Or Impact To Patient 12 12
Malunion of Bone 10 10
Reaction 9 9
Discomfort 7 7
No Patient Involvement 5 5
Swelling 5 5
Arthritis 3 3
Injury 3 3
No Information 3 3
Death 2 2
Device Embedded In Tissue or Plaque 2 2
Not Applicable 2 2
Calcium Deposits/Calcification 2 2
Irritation 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Joint Dislocation 2 2
Osteolysis 2 2
Ambulation Difficulties 1 1
No Known Impact Or Consequence To Patient 1 1
Physical Asymmetry 1 1
Sedation 1 1
Ischemia 1 1
Loss of Range of Motion 1 1
Inflammation 1 1
Dysphagia/ Odynophagia 1 1
Fall 1 1
Swelling/ Edema 1 1

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