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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device clip, aneurysm
Product CodeHCH
Regulation Number 882.5200
Device Class 2


Premarket Reviews
ManufacturerDecision
MIZUHO AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
PETER LAZIC GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 1 1
2018 19 19
2019 9 9
2020 9 9
2021 13 13
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 12 12
Difficult to Open or Close 8 8
Material Integrity Problem 5 5
Improper or Incorrect Procedure or Method 5 5
Loosening of Implant Not Related to Bone-Ingrowth 4 4
Patient Device Interaction Problem 3 3
Material Twisted/Bent 3 3
Defective Component 2 2
Failure to Align 2 2
Migration or Expulsion of Device 2 2
Break 2 2
Fracture 2 2
Positioning Problem 2 2
Device Operates Differently Than Expected 2 2
Device Handling Problem 2 2
Insufficient Information 1 1
Migration 1 1
Firing Problem 1 1
Loose or Intermittent Connection 1 1
Difficult to Fold, Unfold or Collapse 1 1
Device Difficult to Setup or Prepare 1 1
Product Quality Problem 1 1
Failure to Form Staple 1 1
Defective Device 1 1
Component or Accessory Incompatibility 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Deformation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 17 17
No Consequences Or Impact To Patient 10 10
Aneurysm 7 7
Insufficient Information 7 7
No Clinical Signs, Symptoms or Conditions 4 4
Patient Problem/Medical Problem 2 2
No Code Available 2 2
Failure of Implant 2 2
Swelling 1 1
Ruptured Aneurysm 1 1
Foreign Body Reaction 1 1
Hemorrhage/Bleeding 1 1
Intracranial Hemorrhage 1 1
Brain Injury 1 1
Loss of consciousness 1 1
No Patient Involvement 1 1
Foreign Body In Patient 1 1

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