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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 17 17

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 120 120
Fracture 65 65
Break 13 13
Appropriate Term/Code Not Available 11 11
Misfire 7 10
Manufacturing, Packaging or Shipping Problem 5 5
Failure to Fire 5 5
Patient-Device Incompatibility 4 4
Material Integrity Problem 4 4
Detachment of Device or Device Component 4 4
Insufficient Information 3 3
Therapeutic or Diagnostic Output Failure 3 3
Use of Device Problem 3 3
Retraction Problem 3 3
Device Dislodged or Dislocated 3 3
Material Twisted/Bent 2 2
Device Handling Problem 2 2
Firing Problem 2 2
Compatibility Problem 1 1
Material Split, Cut or Torn 1 1
Malposition of Device 1 1
Physical Resistance/Sticking 1 1
Crack 1 1
Defective Component 1 1
Defective Device 1 1
Positioning Problem 1 1
Ejection Problem 1 1
Difficult to Insert 1 1
Obstruction of Flow 1 1
Difficult or Delayed Activation 1 1
Failure to Cut 1 1
Lack of Effect 1 1
Material Rupture 1 1
Material Protrusion/Extrusion 1 1
Activation Failure 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 120 123
Hematoma 34 34
Insufficient Information 28 28
Hematuria 22 22
Hemorrhage/Bleeding 21 21
Pain 18 18
Urinary Tract Infection 15 15
Urinary Retention 11 11
Low Blood Pressure/ Hypotension 6 6
Abdominal Pain 6 6
Dysuria 5 5
Foreign Body In Patient 5 5
Sepsis 4 4
Unspecified Tissue Injury 4 4
Urinary Incontinence 3 3
Syncope/Fainting 3 3
Embolism/Embolus 2 2
Heart Failure/Congestive Heart Failure 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Pulmonary Embolism 2 2
Renal Failure 2 2
Urinary Frequency 2 2
Discomfort 2 2
Needle Stick/Puncture 2 2
Rash 2 2
Incontinence 2 2
Itching Sensation 1 1
Local Reaction 1 1
Hypovolemic Shock 1 1
Failure of Implant 1 1
High Blood Pressure/ Hypertension 1 1
Anemia 1 1
Bacterial Infection 1 1
Bruise/Contusion 1 1
Calcium Deposits/Calcification 1 1
Cardiac Arrest 1 1
Extravasation 1 1
Fever 1 1
Granuloma 1 1
Sleep Dysfunction 1 1
Scar Tissue 1 1
Device Embedded In Tissue or Plaque 1 1
Cancer 1 1
Electrolyte Imbalance 1 1
Stenosis 1 1
Abdominal Distention 1 1
Pseudoaneurysm 1 1
Swelling/ Edema 1 1
Hyponatremia 1 1
Sexual Dysfunction 1 1

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