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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
Regulation Description Surgical mesh.
Product CodeEZX
Regulation Number 878.3300
Device Class 2

MDR Year MDR Reports MDR Events
2020 25 25
2021 35 35
2022 4 4
2023 5 5
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 50 50
Migration 9 9
Fracture 4 4
Appropriate Term/Code Not Available 4 4
Patient Device Interaction Problem 3 3
No Apparent Adverse Event 3 3
Break 2 2
Entrapment of Device 1 1
Migration or Expulsion of Device 1 1
Material Puncture/Hole 1 1
Device Dislodged or Dislocated 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 19 19
Non-union Bone Fracture 12 12
No Code Available 9 9
Unspecified Infection 7 7
Insufficient Information 7 7
Unspecified Tissue Injury 7 7
No Clinical Signs, Symptoms or Conditions 6 6
Hematoma 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Failure of Implant 5 5
Post Operative Wound Infection 5 5
Nerve Damage 5 5
Dysphagia/ Odynophagia 5 5
Physical Asymmetry 5 5
No Known Impact Or Consequence To Patient 4 4
Perforation of Vessels 4 4
Cerebrospinal Fluid Leakage 4 4
Speech Disorder 3 3
Bone Fracture(s) 3 3
Foreign Body In Patient 3 3
Swelling/ Edema 3 3
Unspecified Musculoskeletal problem 2 2
Unspecified Nervous System Problem 2 2
Injury 2 2
Thrombosis/Thrombus 2 2
Osteolysis 2 2
Deformity/ Disfigurement 2 2
Spinal Cord Injury 2 2
Pulmonary Embolism 2 2
Wound Dehiscence 1 1
Death 1 1
Decreased Sensitivity 1 1
Cardiac Arrest 1 1
Visual Disturbances 1 1
Weakness 1 1
Depression 1 1
Pseudoaneurysm 1 1
Thromboembolism 1 1

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