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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
2021 35 35
2022 4 6
2023 5 5
2024 5 5
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 34 35
Migration 9 11
Appropriate Term/Code Not Available 4 4
Patient Device Interaction Problem 3 3
Device Dislodged or Dislocated 2 2
Break 1 1
Entrapment of Device 1 1
Fracture 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Non-union Bone Fracture 11 11
Insufficient Information 8 8
Pain 8 10
Unspecified Tissue Injury 7 7
No Clinical Signs, Symptoms or Conditions 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 6
Unspecified Infection 5 5
Hematoma 5 5
Post Operative Wound Infection 5 5
Nerve Damage 5 5
Physical Asymmetry 5 5
Failure of Implant 4 4
Bone Fracture(s) 4 4
Dysphagia/ Odynophagia 4 4
Perforation of Vessels 4 4
Cerebrospinal Fluid Leakage 4 4
Speech Disorder 3 3
Swelling/ Edema 3 3
Unspecified Musculoskeletal problem 2 2
Unspecified Nervous System Problem 2 2
Thrombosis/Thrombus 2 2
Osteolysis 2 2
Pulmonary Embolism 2 2
Decreased Sensitivity 1 1
Wound Dehiscence 1 1
Nicks, cuts or tears of dura or other tissues by device 1 1
Visual Disturbances 1 1
Foreign Body In Patient 1 1
Depression 1 2
Thromboembolism 1 1
Deformity/ Disfigurement 1 1
Spinal Cord Injury 1 1

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