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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device implantable transprostatic tissue retractor system
Regulation Description Implantable transprostatic tissue retractor system.
Definition The treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men age 50 and above.
Product CodePEW
Regulation Number 876.5530
Device Class 2


Premarket Reviews
ManufacturerDecision
NEOTRACT, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 50 50
2022 55 58
2023 52 52
2024 37 37
2025 69 69
2026 31 31

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 123 123
Fracture 65 65
Break 15 15
Appropriate Term/Code Not Available 11 11
Misfire 7 10
Insufficient Information 5 5
Manufacturing, Packaging or Shipping Problem 5 5
Material Integrity Problem 5 5
Detachment of Device or Device Component 5 5
Failure to Fire 5 5
Patient-Device Incompatibility 4 4
Use of Device Problem 4 4
Firing Problem 3 3
Therapeutic or Diagnostic Output Failure 3 3
Device Dislodged or Dislocated 3 3
Retraction Problem 3 3
Defective Device 2 2
Material Twisted/Bent 2 2
Device Handling Problem 2 2
Mechanical Jam 1 1
Deformation Due to Compressive Stress 1 1
Improper or Incorrect Procedure or Method 1 1
Calcified 1 1
Unexpected Therapeutic Results 1 1
Activation Failure 1 1
Material Protrusion/Extrusion 1 1
Material Deformation 1 1
Material Rupture 1 1
Lack of Effect 1 1
Failure to Cut 1 1
Difficult or Delayed Activation 1 1
Obstruction of Flow 1 1
Difficult to Insert 1 1
Ejection Problem 1 1
Positioning Problem 1 1
Defective Component 1 1
Crack 1 1
Physical Resistance/Sticking 1 1
Malposition of Device 1 1
Material Split, Cut or Torn 1 1
Compatibility Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 129 132
Hematoma 35 35
Insufficient Information 30 30
Hemorrhage/Bleeding 22 22
Hematuria 22 22
Pain 18 18
Urinary Tract Infection 15 15
Urinary Retention 11 11
Abdominal Pain 6 6
Low Blood Pressure/ Hypotension 6 6
Dysuria 6 6
Foreign Body In Patient 5 5
Unspecified Tissue Injury 4 4
Sepsis 4 4
Syncope/Fainting 3 3
Urinary Incontinence 3 3
Bruise/Contusion 2 2
Pulmonary Embolism 2 2
Urinary Frequency 2 2
Renal Failure 2 2
Heart Failure/Congestive Heart Failure 2 2
Discomfort 2 2
Needle Stick/Puncture 2 2
Rash 2 2
Incontinence 2 2
Embolism/Embolus 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Electrolyte Imbalance 1 1
Fever 1 1
Cardiac Arrest 1 1
Easy Bruising 1 1
Local Reaction 1 1
Itching Sensation 1 1
Anemia 1 1
Scar Tissue 1 1
Abdominal Distention 1 1
Calcium Deposits/Calcification 1 1
Extravasation 1 1
Skin Inflammation/ Irritation 1 1
Stenosis 1 1
Failure of Implant 1 1
Swelling/ Edema 1 1
Pseudoaneurysm 1 1
Bacterial Infection 1 1
Drug Resistant Bacterial Infection 1 1
Hyponatremia 1 1
Cancer 1 1
Sexual Dysfunction 1 1
Granuloma 1 1
Sleep Dysfunction 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Neotract Inc II Aug-05-2022
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