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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device mesh, surgical, synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed
Definition Bridging material to attach the vaginal apex to the anterior longitudinal ligament of the sacrum; Procedures include abdominal sacrocolpopexy and laparoscopic sacrocolpopexy.
Product CodeOTO
Regulation Number 878.3300
Device Class 2

MDR Year MDR Reports MDR Events
2019 347 347
2020 151 151
2021 290 290
2022 110 110
2023 101 101
2024 28 28

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 628 628
Migration 155 155
Appropriate Term/Code Not Available 101 101
Insufficient Information 46 46
Material Protrusion/Extrusion 22 22
Material Erosion 19 19
Break 15 15
Material Split, Cut or Torn 14 14
Device Appears to Trigger Rejection 12 12
Missing Information 12 12
Migration or Expulsion of Device 9 9
Patient-Device Incompatibility 9 9
Defective Device 7 7
Patient Device Interaction Problem 6 6
Detachment of Device or Device Component 5 5
Material Deformation 4 4
Stretched 3 3
Positioning Problem 3 3
Mechanical Problem 2 2
Collapse 2 2
Fluid/Blood Leak 2 2
Material Twisted/Bent 2 2
Expiration Date Error 2 2
Fracture 1 1
Material Integrity Problem 1 1
Product Quality Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Degraded 1 1
Material Frayed 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Malposition of Device 1 1
Unintended Movement 1 1
Pressure Problem 1 1
Positioning Failure 1 1
Material Too Rigid or Stiff 1 1
Expulsion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 452 452
Erosion 369 369
Injury 179 179
Prolapse 143 143
Incontinence 130 130
Urinary Tract Infection 116 116
No Code Available 101 101
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 93 93
Micturition Urgency 93 93
Unspecified Infection 92 92
Urinary Incontinence 80 80
Dyspareunia 79 79
Hemorrhage/Bleeding 79 79
Abnormal Vaginal Discharge 78 78
Urinary Frequency 70 70
Abdominal Pain 64 64
Not Applicable 63 63
Insufficient Information 60 60
Urinary Retention 59 59
Dysuria 50 50
Adhesion(s) 49 49
Inflammation 49 49
Constipation 45 45
Scar Tissue 44 44
Obstruction/Occlusion 38 38
Discomfort 37 37
Bacterial Infection 32 32
Blood Loss 30 30
Fever 29 29
Hematuria 29 29
Cramp(s) /Muscle Spasm(s) 26 26
Abscess 26 26
Deformity/ Disfigurement 26 26
No Information 25 25
Internal Organ Perforation 24 24
Fistula 23 23
Burning Sensation 23 23
Nerve Damage 21 21
Hematoma 21 21
Intermenstrual Bleeding 21 21
Genital Bleeding 21 21
Muscle Weakness 18 18
Nausea 18 18
Pocket Erosion 17 17
Anxiety 16 16
No Clinical Signs, Symptoms or Conditions 15 15
Fecal Incontinence 14 14
Skin Erosion 14 14
Depression 14 14
Hernia 13 13
Failure of Implant 13 13
Fatigue 13 13
Diarrhea 13 13
Swelling/ Edema 13 13
Kidney Infection 12 12
Unspecified Kidney or Urinary Problem 12 12
Disability 12 12
Fungal Infection 12 12
Vomiting 11 11
Itching Sensation 11 11
Unspecified Mental, Emotional or Behavioural Problem 11 11
Wound Dehiscence 10 10
Numbness 10 10
Perforation of Vessels 9 9
Anemia 9 9
Emotional Changes 9 9
Foreign Body Reaction 9 9
Sexual Dysfunction 9 9
Unspecified Tissue Injury 9 9
Fibrosis 8 8
Sepsis 8 8
Tissue Damage 8 8
Scarring 7 7
Headache 7 7
Hypersensitivity/Allergic reaction 7 7
Erythema 7 7
Foreign Body In Patient 7 7
Vesicovaginal Fistula 6 6
Osteomyelitis 6 6
Cyst(s) 6 6
Perforation 6 6
Swelling 6 6
Abdominal Distention 6 6
Dizziness 5 5
Muscle Spasm(s) 5 5
Purulent Discharge 5 5
Implant Pain 5 5
Paresthesia 4 4
Skin Inflammation/ Irritation 4 4
Bowel Perforation 4 4
Granuloma 4 4
Exposure to Body Fluids 4 4
Calcium Deposits/Calcification 4 4
Necrosis 4 4
Neuropathy 4 4
Rash 4 4
No Consequences Or Impact To Patient 4 4
Weight Changes 4 4
Ambulation Difficulties 4 4
Diaphoresis 3 3

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