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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
C4 IMAGING LLC
  SUBSTANTIALLY EQUIVALENT 1
DEVICOR MEDICAL PRODUCTS, INC
  SUBSTANTIALLY EQUIVALENT 1
DEVICOR MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 5
ELUCENT MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ENDOMAGNETICS LTD
  SUBSTANTIALLY EQUIVALENT 2
HEALTH BEACONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
INRAD INC.
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEM, INC.
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MOLLI SURGICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
MOLLI SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
SOMATEX MEDICAL TECHNOLOGIES GMBH
  SUBSTANTIALLY EQUIVALENT 1
SURGMARK GMBH
  SUBSTANTIALLY EQUIVALENT 1
VIEW POINT MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 45 45
2021 82 82
2022 100 100
2023 142 142
2024 247 247
2025 28 28

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 300 300
Migration 31 31
Use of Device Problem 27 27
Patient-Device Incompatibility 22 22
Detachment of Device or Device Component 17 17
Break 14 14
Positioning Failure 13 13
Device Markings/Labelling Problem 11 11
Difficult to Remove 11 11
Device Contamination with Chemical or Other Material 9 9
Separation Failure 8 8
Activation, Positioning or Separation Problem 7 7
Poor Quality Image 6 6
Entrapment of Device 6 6
Material Fragmentation 6 6
Incorrect Measurement 6 6
Migration or Expulsion of Device 6 6
Therapeutic or Diagnostic Output Failure 6 6
Mechanical Problem 6 6
Component Misassembled 5 5
Material Split, Cut or Torn 5 5
Device-Device Incompatibility 4 4
Activation Problem 4 4
Material Twisted/Bent 4 4
Insufficient Information 4 4
Patient Device Interaction Problem 4 4
Appropriate Term/Code Not Available 4 4
Output Problem 4 4
Improper or Incorrect Procedure or Method 3 3
Unable to Obtain Readings 3 3
Component or Accessory Incompatibility 3 3
Retraction Problem 3 3
Expiration Date Error 3 3
Difficult to Insert 3 3
Fracture 3 3
Component Missing 3 3
Device Slipped 3 3
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Material Discolored 2 2
Malposition of Device 2 2
Expulsion 2 2
Premature Activation 2 2
Failure to Advance 2 2
Audible Prompt/Feedback Problem 2 2
Unexpected Therapeutic Results 2 2
Difficult or Delayed Activation 2 2
Device Sensing Problem 2 2
Positioning Problem 2 2
Tear, Rip or Hole in Device Packaging 2 2
Thermal Decomposition of Device 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Breast Discomfort/Pain 180 180
No Clinical Signs, Symptoms or Conditions 171 171
Erythema 62 62
Swelling/ Edema 53 53
Foreign Body In Patient 52 52
Sleep Dysfunction 47 47
Hypersensitivity/Allergic reaction 38 38
Pain 37 37
Bacterial Infection 37 37
Seroma 37 37
Hematoma 35 35
Itching Sensation 28 28
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 23 23
Unspecified Infection 18 18
Necrosis 18 18
Failure of Implant 17 17
Insufficient Information 17 17
Deformity/ Disfigurement 17 17
Inflammation 15 15
Scar Tissue 15 15
Hemorrhage/Bleeding 15 15
Erosion 14 14
Bruise/Contusion 14 14
Burning Sensation 12 12
Implant Pain 12 12
Post Operative Wound Infection 10 10
Foreign Body Reaction 9 9
Post Traumatic Wound Infection 9 9
Rash 8 8
Anxiety 8 8
Abscess 7 7
Device Embedded In Tissue or Plaque 7 7
Impaired Healing 7 7
Discomfort 6 6
Fistula 6 6
Fluid Discharge 5 5
No Known Impact Or Consequence To Patient 5 5
Pancreatitis 5 5
Nodule 5 5
Wound Dehiscence 5 5
Unspecified Tissue Injury 4 4
Reaction 4 4
Abdominal Pain 4 4
Fever 4 4
Local Reaction 4 4
Hair Loss 4 4
Swollen Lymph Nodes/Glands 4 4
Purulent Discharge 4 4
Increased Sensitivity 3 3
Cancer 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Carbon Medical Technologies, Inc. II Jan-30-2023
2 Devicor Medical Products Inc II May-23-2022
3 Elucent Medical Inc II Jan-06-2025
4 Hologic, Inc I Nov-26-2024
5 Hologic, Inc I May-03-2024
6 Hologic, Inc II Sep-30-2022
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