• 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 mesh, surgical, metal
Product CodeEZX
Regulation Number 878.3300
Device Class 2

MDR Year MDR Reports MDR Events
2019 29 29
2020 25 25
2021 35 35
2022 4 4
2023 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 62 62
Migration 11 11
No Apparent Adverse Event 10 10
Break 5 5
Fracture 4 4
Appropriate Term/Code Not Available 4 4
Patient Device Interaction Problem 3 3
Migration or Expulsion of Device 2 2
Material Puncture/Hole 1 1
Device Dislodged or Dislocated 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 25 25
Pain 21 21
Non-union Bone Fracture 12 12
Unspecified Infection 10 10
Injury 8 8
Hematoma 7 7
Nerve Damage 6 6
No Clinical Signs, Symptoms or Conditions 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Unspecified Tissue Injury 5 5
Physical Asymmetry 5 5
Failure of Implant 5 5
Cerebrospinal Fluid Leakage 5 5
Bone Fracture(s) 5 5
No Known Impact Or Consequence To Patient 5 5
Post Operative Wound Infection 5 5
Dysphagia/ Odynophagia 4 4
Foreign Body In Patient 3 3
Osteolysis 3 3
Impaired Healing 3 3
Perforation of Vessels 3 3
Swelling/ Edema 3 3
Insufficient Information 3 3
Unspecified Musculoskeletal problem 2 2
Visual Impairment 2 2
Deformity/ Disfigurement 2 2
Depression 1 1
Blood Loss 1 1
Pseudoaneurysm 1 1
Thromboembolism 1 1
Decreased Sensitivity 1 1
Visual Disturbances 1 1
Weakness 1 1
Numbness 1 1
Spinal Cord Injury 1 1
Death 1 1
Wound Dehiscence 1 1
Pulmonary Embolism 1 1
Abscess 1 1
Cardiac Arrest 1 1
Neurological Deficit/Dysfunction 1 1
Paralysis 1 1
Pneumonia 1 1
Loss of Range of Motion 1 1
Unspecified Nervous System Problem 1 1
Thrombosis/Thrombus 1 1

-
-