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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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

MDR Year MDR Reports MDR Events
2017 7 7
2018 11 11
2019 29 29
2020 25 25
2021 35 35

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 58 58
Migration 14 14
No Apparent Adverse Event 11 11
Appropriate Term/Code Not Available 6 6
Break 5 5
Migration or Expulsion of Device 5 5
Fracture 4 4
Patient Device Interaction Problem 2 2
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Leak/Splash 1 1
Torn Material 1 1
Unintended Movement 1 1
Material Puncture/Hole 1 1
Stretched 1 1
Device Dislodged or Dislocated 1 1
Material Protrusion/Extrusion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 31 31
Pain 24 24
Non-union Bone Fracture 10 10
Injury 8 8
No Known Impact Or Consequence To Patient 7 7
Unspecified Infection 6 6
Hematoma 6 6
No Clinical Signs, Symptoms or Conditions 6 6
Bone Fracture(s) 5 5
Nerve Damage 5 5
Failure of Implant 4 4
Dysphagia/ Odynophagia 4 4
Cerebrospinal Fluid Leakage 4 4
Foreign Body In Patient 4 4
Impaired Healing 4 4
Numbness 4 4
Post Operative Wound Infection 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Physical Asymmetry 4 4
Swelling/ Edema 3 3
Insufficient Information 3 3
Unspecified Tissue Injury 3 3
Perforation of Vessels 3 3
Visual Impairment 2 2
Neurological Deficit/Dysfunction 2 2
Neuropathy 1 1
Paralysis 1 1
Pneumonia 1 1
Loss of Range of Motion 1 1
Spinal Column Injury 1 1
Death 1 1
Abscess 1 1
Cardiac Arrest 1 1
Fever 1 1
Visual Disturbances 1 1
Weakness 1 1
Deformity/ Disfigurement 1 1
Osteolysis 1 1
Blood Loss 1 1
Pseudoaneurysm 1 1
Spinal Cord Injury 1 1
Patient Problem/Medical Problem 1 1
Not Applicable 1 1

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