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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
Device marker, radiographic, implantable
Regulation Description Implantable clip.
Product CodeNEU
Regulation Number 878.4300
Device Class 2


Premarket Reviews
ManufacturerDecision
BARD PERIPHERAL VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 2
C4 IMAGING LLC
  SUBSTANTIALLY EQUIVALENT 1
CIANNA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
DEVICOR MEDICAL PRODUCTS, INC
  SUBSTANTIALLY EQUIVALENT 1
DEVICOR MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 3
ELUCENT MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
ELUCENT MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ENDOMAGNETICS LTD.
  SUBSTANTIALLY EQUIVALENT 1
FOCAL THERAPEUTICS
  SUBSTANTIALLY EQUIVALENT 1
HEALTH BEACONS, INC.
  SUBSTANTIALLY EQUIVALENT 3
INRAD INC.
  SUBSTANTIALLY EQUIVALENT 1
MOLLI SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SCION MEDICAL TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
SOMATEX MEDICAL TECHNOLOGIES GMBH
  SUBSTANTIALLY EQUIVALENT 3
SONAVEX, INC.
  SUBSTANTIALLY EQUIVALENT 1
VIEW POINT MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
VISCUS BIOLOGICS, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 56 56
2017 69 69
2018 66 66
2019 58 58
2020 45 45
2021 52 52

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 71 71
Device Damaged by Another Device 32 32
Bent 28 28
Patient-Device Incompatibility 27 27
Positioning Failure 19 19
Material Fragmentation 15 15
Signal Artifact/Noise 15 15
Activation, Positioning or SeparationProblem 14 14
Detachment of Device or Device Component 14 14
Break 13 13
Difficult to Remove 12 12
Use of Device Problem 9 9
Patient Device Interaction Problem 9 9
Device Operates Differently Than Expected 8 8
Component Missing 7 7
Device Contamination with Chemical or Other Material 7 7
Poor Quality Image 6 6
Mechanical Problem 5 5
Material Split, Cut or Torn 5 5
Material Twisted/Bent 5 5
Insufficient Information 4 4
Separation Failure 4 4
Material Protrusion/Extrusion 4 4
Activation Problem 4 4
Difficult to Insert 4 4
Failure to Advance 4 4
Detachment Of Device Component 3 3
Device Markings/Labelling Problem 3 3
Retraction Problem 3 3
Material Separation 3 3
Migration or Expulsion of Device 3 3
Failure to Eject 3 3
Therapeutic or Diagnostic Output Failure 3 3
Appropriate Term/Code Not Available 2 2
Expulsion 2 2
Fracture 2 2
Failure to Deliver 2 2
Material Deformation 2 2
Migration 2 2
Tear, Rip or Hole in Device Packaging 2 2
Material Discolored 2 2
Entrapment of Device 2 2
Failure to Fire 2 2
Thermal Decomposition of Device 2 2
Improper or Incorrect Procedure or Method 2 2
Defective Component 1 1
Malposition of Device 1 1
Chemical Problem 1 1
Contamination 1 1
Difficult or Delayed Positioning 1 1
Device Appears to Trigger Rejection 1 1
Sticking 1 1
Unexpected Therapeutic Results 1 1
Audible Prompt/Feedback Problem 1 1
Positioning Problem 1 1
Activation Failure 1 1
Device Sensing Problem 1 1
Defective Device 1 1
Device Slipped 1 1
Degraded 1 1
Nonstandard Device 1 1
Premature Activation 1 1
Material Puncture/Hole 1 1
Device Dislodged or Dislocated 1 1
No Apparent Adverse Event 1 1
Output Problem 1 1
Packaging Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 104 104
No Known Impact Or Consequence To Patient 38 38
Foreign Body In Patient 38 38
Reaction 28 28
Hypersensitivity/Allergic reaction 26 26
Patient Problem/Medical Problem 20 20
Pain 18 18
No Clinical Signs, Symptoms or Conditions 13 13
Foreign Body Reaction 12 12
Device Embedded In Tissue or Plaque 12 12
No Patient Involvement 8 8
No Code Available 7 7
Insufficient Information 6 6
Inflammation 5 5
Hematoma 5 5
Breast Discomfort/Pain 5 5
No Information 5 5
Unspecified Infection 5 5
Hemorrhage/Bleeding 4 4
Rash 4 4
Swelling 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Failure of Implant 3 3
Wound Dehiscence 3 3
Burning Sensation 3 3
Discomfort 3 3
Blood Loss 3 3
Bronchospasm 2 2
Weight Changes 2 2
Post Operative Wound Infection 2 2
Injury 2 2
Anxiety 2 2
Itching Sensation 2 2
Seroma 2 2
Tissue Damage 2 2
Burn, Thermal 2 2
Skin Irritation 2 2
Septic Shock 1 1
Discharge 1 1
Wheal(s) 1 1
Numbness 1 1
Reaction, Injection Site 1 1
Sweating 1 1
Palpitations 1 1
Abscess 1 1
Anemia 1 1
Arthritis 1 1
Erythema 1 1
Fatigue 1 1
Glaucoma 1 1
Irritation 1 1
Neurological Deficit/Dysfunction 1 1
Increased Sensitivity 1 1
Unintended Radiation Exposure 1 1
Implant Pain 1 1
Visual Impairment 1 1
Tinnitus 1 1
Granuloma 1 1
Hair Loss 1 1
Local Reaction 1 1
Muscular Rigidity 1 1
Necrosis 1 1
Abdominal Pain 1 1
Asthma 1 1
Bacterial Infection 1 1
Ecchymosis 1 1
Urticaria 1 1
Arthralgia 1 1
Inadequate Pain Relief 1 1
Shaking/Tremors 1 1
Breast Mass 1 1
Tissue Breakdown 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Somatex Medical Technologies GmbH II Jan-24-2018
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