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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
2018 11 11
2019 29 29
2020 25 25
2021 35 35
2022 2 2
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 14 14
No Apparent Adverse Event 10 10
Appropriate Term/Code Not Available 5 5
Break 5 5
Fracture 4 4
Patient Device Interaction Problem 3 3
Migration or Expulsion of Device 3 3
Material Puncture/Hole 1 1
Stretched 1 1
Device Dislodged or Dislocated 1 1
Material Protrusion/Extrusion 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Leak/Splash 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 28 28
Pain 20 20
Non-union Bone Fracture 12 12
Unspecified Infection 10 10
Injury 8 8
Hematoma 7 7
Nerve Damage 6 6
No Known Impact Or Consequence To Patient 6 6
No Clinical Signs, Symptoms or Conditions 6 6
Unspecified Tissue Injury 5 5
Physical Asymmetry 5 5
Failure of Implant 5 5
Cerebrospinal Fluid Leakage 5 5
Bone Fracture(s) 5 5
Post Operative Wound Infection 5 5
Numbness 4 4
Foreign Body In Patient 4 4
Dysphagia/ Odynophagia 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Swelling/ Edema 3 3
Insufficient Information 3 3
Osteolysis 3 3
Impaired Healing 3 3
Perforation of Vessels 3 3
Visual Impairment 2 2
Deformity/ Disfigurement 2 2
Neurological Deficit/Dysfunction 2 2
Unspecified Musculoskeletal problem 2 2
Not Applicable 1 1
Unspecified Nervous System Problem 1 1
Thrombosis/Thrombus 1 1
Paralysis 1 1
Pneumonia 1 1
Loss of Range of Motion 1 1
Spinal Column Injury 1 1
Death 1 1
Wound Dehiscence 1 1
Pulmonary Embolism 1 1
Abscess 1 1
Cardiac Arrest 1 1
Visual Disturbances 1 1
Weakness 1 1
Patient Problem/Medical Problem 1 1
Spinal Cord Injury 1 1
Blood Loss 1 1
Pseudoaneurysm 1 1
Thromboembolism 1 1
Decreased Sensitivity 1 1

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