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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
2019 29 29
2020 25 25
2021 35 35
2022 4 4
2023 5 5
2024 1 1

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
Appropriate Term/Code Not Available 4 4
Fracture 4 4
Patient Device Interaction Problem 3 3
Migration or Expulsion of Device 2 2
Material Puncture/Hole 1 1
Improper or Incorrect Procedure or Method 1 1
Device Dislodged or Dislocated 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Entrapment of Device 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 11 11
Injury 8 8
Hematoma 8 8
Unspecified Tissue Injury 7 7
No Clinical Signs, Symptoms or Conditions 6 6
Nerve Damage 6 6
Post Operative Wound Infection 5 5
Failure of Implant 5 5
Dysphagia/ Odynophagia 5 5
Bone Fracture(s) 5 5
Cerebrospinal Fluid Leakage 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
No Known Impact Or Consequence To Patient 5 5
Physical Asymmetry 5 5
Insufficient Information 4 4
Perforation of Vessels 4 4
Foreign Body In Patient 4 4
Osteolysis 3 3
Impaired Healing 3 3
Swelling/ Edema 3 3
Thrombosis/Thrombus 2 2
Unspecified Musculoskeletal problem 2 2
Deformity/ Disfigurement 2 2
Speech Disorder 2 2
Visual Impairment 2 2
Pulmonary Embolism 2 2
Abscess 1 1
Cardiac Arrest 1 1
Death 1 1
Visual Disturbances 1 1
Weakness 1 1
Paralysis 1 1
Pneumonia 1 1
Loss of Range of Motion 1 1
Unspecified Nervous System Problem 1 1
Wound Dehiscence 1 1
Blood Loss 1 1
Pseudoaneurysm 1 1
Thromboembolism 1 1
Decreased Sensitivity 1 1
Depression 1 1
Neurological Deficit/Dysfunction 1 1
Numbness 1 1
Spinal Cord Injury 1 1

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