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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 3

MDR Year MDR Reports MDR Events
2020 65 65
2021 50 50
2022 55 55
2023 52 52
2024 37 37
2025 33 33

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 136 136
Fracture 87 87
Break 13 13
Misfire 12 12
Failure to Fire 6 6
Manufacturing, Packaging or Shipping Problem 4 4
Patient-Device Incompatibility 3 3
Therapeutic or Diagnostic Output Failure 2 2
Material Twisted/Bent 2 2
Device Dislodged or Dislocated 2 2
Compatibility Problem 1 1
Mechanical Problem 1 1
Crack 1 1
Insufficient Information 1 1
Defective Component 1 1
Positioning Problem 1 1
Use of Device Problem 1 1
Failure to Cut 1 1
Delivered as Unsterile Product 1 1
Device Handling Problem 1 1
Retraction Problem 1 1
Material Protrusion/Extrusion 1 1
Activation Failure 1 1
Appropriate Term/Code Not Available 1 1
Unexpected Therapeutic Results 1 1
Calcified 1 1
Improper or Incorrect Procedure or Method 1 1
Deformation Due to Compressive Stress 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 96 96
Hematoma 40 40
Hematuria 25 25
No Known Impact Or Consequence To Patient 22 22
Hemorrhage/Bleeding 22 22
Pain 18 18
Urinary Tract Infection 18 18
Insufficient Information 18 18
Urinary Retention 10 10
Sepsis 10 10
Low Blood Pressure/ Hypotension 6 6
Foreign Body In Patient 5 5
Renal Failure 4 4
Dysuria 4 4
Syncope/Fainting 3 3
Abdominal Pain 3 3
Death 3 3
Needle Stick/Puncture 3 3
Unspecified Tissue Injury 3 3
Heart Failure/Congestive Heart Failure 2 2
Rash 2 2
Incontinence 2 2
No Consequences Or Impact To Patient 2 2
Embolism/Embolus 2 2
Urinary Incontinence 2 2
Failure of Implant 2 2
No Code Available 2 2
Pulmonary Embolism 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Bacterial Infection 1 1
Urinary Frequency 1 1
Pseudoaneurysm 1 1
Swelling/ Edema 1 1
Cancer 1 1
Sexual Dysfunction 1 1
Extravasation 1 1
Calcium Deposits/Calcification 1 1
Granuloma 1 1
Device Embedded In Tissue or Plaque 1 1
Stenosis 1 1
Bruise/Contusion 1 1
Tachycardia 1 1
Scar Tissue 1 1
Discomfort 1 1
No Patient Involvement 1 1
Fever 1 1
Cardiac Arrest 1 1
Electrolyte Imbalance 1 1
Anemia 1 1
Itching Sensation 1 1

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