TPLC - Total Product Life Cycle

show TPLC since

Device	marker, radiographic, implantable
Regulation Description	Implantable clip.
Product Code	NEU
Regulation Number	878.4300
Device Class	2

Premarket Reviews
Manufacturer	Decision
BARD PERIPHERAL VASCULAR, INC.
	SUBSTANTIALLY EQUIVALENT	1
BREAST-MED, INC.
	SUBSTANTIALLY EQUIVALENT	1
CARBON MEDICAL TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
DEVICOR MEDICAL PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	6
ELUCENT MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
ENDOMAGNETICS LTD.,
	SUBSTANTIALLY EQUIVALENT	2
INRAD, INC.
	SUBSTANTIALLY EQUIVALENT	1
MERIT MEDICAL SYSTEM, INC.
	SUBSTANTIALLY EQUIVALENT	1
MERIT MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	2
MOLLI SURGICAL, INC.
	SUBSTANTIALLY EQUIVALENT	5
SOMATEX MEDICAL TECHNOLOGIES GMBH
	SUBSTANTIALLY EQUIVALENT	1
STRYKER ENDOSCOPY
	SUBSTANTIALLY EQUIVALENT	1
SURGMARK GMBH
	SUBSTANTIALLY EQUIVALENT	1
VIEW POINT MEDICAL
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	567	567
Migration	56	56
Use of Device Problem	47	47
Break	29	29
Fracture	26	26
Migration or Expulsion of Device	24	24
Positioning Failure	22	22
Detachment of Device or Device Component	17	17
Patient-Device Incompatibility	16	16
Difficult to Remove	16	16
Patient Device Interaction Problem	14	14
Device Markings/Labelling Problem	12	12
Insufficient Information	12	12
Incorrect, Inadequate or Imprecise Result or Readings	12	12
Appropriate Term/Code Not Available	11	11
Device Contamination with Chemical or Other Material	10	10
Separation Failure	10	10
Device Appears to Trigger Rejection	9	9
Therapeutic or Diagnostic Output Failure	9	9
Incorrect Measurement	6	6
Activation, Positioning or Separation Problem	6	6
No Apparent Adverse Event	6	6
Poor Quality Image	6	6
Difficult to Insert	6	6
Nonstandard Device	6	6
Material Fragmentation	6	6
Entrapment of Device	5	5
Component Misassembled	5	5
Defective Device	5	5
Material Deformation	4	4
Device Dislodged or Dislocated	4	4
Component Missing	4	4
Unintended Movement	4	4
Activation Problem	4	4
Communication or Transmission Problem	4	4
Malposition of Device	4	4
Mechanical Problem	4	4
Material Split, Cut or Torn	4	4
Device-Device Incompatibility	4	4
Positioning Problem	3	3
Expiration Date Error	3	3
Unexpected Therapeutic Results	3	3
Unable to Obtain Readings	3	3
Improper or Incorrect Procedure or Method	3	3
Output Problem	3	3
Material Twisted/Bent	3	3
Activation Failure	3	3
Premature Activation	3	3
Component or Accessory Incompatibility	3	3
Device Sensing Problem	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Breast Discomfort/Pain	393	393
No Clinical Signs, Symptoms or Conditions	249	249
Swelling/ Edema	140	140
Bacterial Infection	139	139
Erythema	122	122
Seroma	104	104
Sleep Dysfunction	69	69
Hypersensitivity/Allergic reaction	66	66
Foreign Body In Patient	65	65
Deformity/ Disfigurement	63	63
Hematoma	52	52
Breast Mass	51	51
Itching Sensation	48	48
Pain	47	47
Scar Tissue	37	37
Rash	36	36
Necrosis	31	31
Inflammation	30	30
Insufficient Information	29	29
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	27	27
Post Operative Wound Infection	25	25
Abscess	25	25
Impaired Healing	24	24
Erosion	24	24
Unspecified Infection	22	22
Failure of Implant	19	19
Wound Dehiscence	18	18
Hemorrhage/Bleeding	16	16
Skin Inflammation/ Irritation	16	16
Bruise/Contusion	15	15
Burning Sensation	15	15
Fluid Discharge	13	13
Implant Pain	12	12
Post Traumatic Wound Infection	11	11
Foreign Body Reaction	10	10
Discomfort	10	10
Anxiety	9	9
Purulent Discharge	8	8
Fistula	8	8
Localized Skin Lesion	7	7
Local Reaction	7	7
Cellulitis	7	7
Unspecified Tissue Injury	7	7
Skin Discoloration	7	7
Nodule	6	6
Device Embedded In Tissue or Plaque	6	6
Swollen Lymph Nodes/Glands	5	5
Fever	5	5
Pancreatitis	5	5
Skin Erosion	4	4

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	ENDOMAGNETICS LTD	II	Oct-24-2025
4	Elucent Medical Inc	II	Jan-06-2025
5	Hologic, Inc	I	Nov-26-2024
6	Hologic, Inc	I	May-03-2024
7	Hologic, Inc	II	Sep-30-2022
8	Stryker Corporation	II	Feb-17-2026