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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
Regulation Description Surgical mesh.
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
2021 292 301
2022 113 118
2023 101 107
2024 113 114
2025 81 81
2026 40 41

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 411 429
Migration 136 137
Appropriate Device Problem Term/Code Not Available 95 95
Device Appears to Trigger Rejection 20 20
Material Protrusion/Extrusion 18 18
Material Erosion 14 14
Material Split, Cut or Torn 13 15
Patient Device Interaction Problem 6 6
Migration or Expulsion of Device 6 6
Insufficient Device Problem Information 5 5
Material Deformation 4 5
Malposition of Device 4 4
Defective Device 4 5
Break 4 4
Expiration Date Error 3 3
Positioning Problem 3 3
Material Integrity Problem 2 2
Material Too Rigid or Stiff 2 2
Patient-Device Incompatibility 2 2
Stretched 2 2
Fluid/Blood Leak 2 2
Detachment of Device or Device Component 2 2
No Apparent Adverse Event 1 1
Unintended Movement 1 1
Improper or Incorrect Procedure or Method 1 1
Device Markings/Labelling Problem 1 1
Use of Device Problem 1 1
Unsealed Device Packaging 1 1
Material Disintegration 1 1
Pressure Problem 1 1
Missing Information 1 1
Expulsion 1 1
Fracture 1 1
Positioning Failure 1 1
Material Twisted/Bent 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 398 411
Erosion 316 323
Prolapse 151 158
Urinary Tract Infection 128 131
Dyspareunia 118 122
Urinary Incontinence 115 118
Micturition Urgency 104 108
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 97 98
Unspecified Infection 96 101
Abnormal Vaginal Discharge 93 100
Hemorrhage/Blood Loss/Bleeding 91 95
Insufficient Information 82 87
Incontinence 81 88
Urinary Frequency / Polyuria 75 78
Inflammation 72 75
Urinary Retention 70 71
Scar Tissue 64 66
Constipation 60 67
Dysuria 59 60
Adhesion(s) 56 59
Abdominal Pain 49 53
Discomfort 46 49
Cramp(s) /Muscle Spasm(s) 43 44
Hematuria 41 42
Obstruction/Occlusion 40 42
Bacterial Infection 33 34
Fever 32 33
Pelvic Pain 29 29
Nausea 28 28
Deformity/ Disfigurement 27 27
No Clinical Signs, Symptoms or Conditions 27 30
Unspecified Mental, Emotional or Behavioural Problem 26 28
Unspecified Tissue Injury 26 26
Unspecified Kidney or Urinary Problem 26 26
Intermenstrual Bleeding 25 25
Burning Sensation 25 26
Genital Bleeding 24 24
Muscle Weakness/Atrophy 24 26
Abscess 23 26
Fistula 21 23
Hernia 21 21
Depression 21 22
Fecal Incontinence 19 20
Ambulation or Postural Difficulties 19 19
Diarrhea 19 21
Hematoma 18 20
Anxiety 17 20
Vomiting 16 17
Sexual Dysfunction 15 15
Swelling/ Edema 15 17

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