• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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

Device Problems MDRs with this Device Problem Events in those MDRs
Break 136 136
Adverse Event Without Identified Device or Use Problem 98 98
Device-Device Incompatibility 32 32
Unintended Movement 21 21
Migration or Expulsion of Device 8 8
Device Slipped 7 7
Detachment of Device or Device Component 6 6
Material Deformation 6 6
Bent 5 5
Migration 4 4
No Apparent Adverse Event 3 3
Insufficient Information 3 3
Packaging Problem 3 3
Material Twisted/Bent 2 2
Appropriate Term/Code Not Available 2 2
Corroded 2 2
Crack 2 2
Mechanical Problem 1 1
Failure To Adhere Or Bond 1 1
Difficult To Position 1 1
Material Integrity Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Device Operates Differently Than Expected 1 1
Use of Device Problem 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Operating System Becomes Nonfunctional 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 139 139
Failure of Implant 107 107
Non-union Bone Fracture 87 87
Unspecified Infection 46 46
Pain 44 44
Impaired Healing 26 26
Bone Fracture(s) 18 18
No Consequences Or Impact To Patient 12 12
Reaction 9 9
Discomfort 7 7
Swelling 5 5
No Patient Involvement 5 5
No Clinical Signs, Symptoms or Conditions 3 3
No Information 3 3
Injury 3 3
Arthritis 3 3
Calcium Deposits/Calcification 2 2
Death 2 2
Irritation 2 2
Device Embedded In Tissue or Plaque 2 2
Not Applicable 2 2
Joint Dislocation 2 2
Osteolysis 2 2
Ambulation Difficulties 1 1
No Known Impact Or Consequence To Patient 1 1
Ischemia 1 1
Inflammation 1 1
Dysphagia/ Odynophagia 1 1
Fall 1 1
Sedation 1 1
Loss of Range of Motion 1 1

-
-