TPLC - Total Product Life Cycle

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Device	marker, radiographic, implantable
Product Code	NEU
Regulation Number	878.4300
Device Class	2

Premarket Reviews
Manufacturer	Decision
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
FOCAL THERAPEUTICS
	SUBSTANTIALLY EQUIVALENT	1
HEALTH BEACONS, INC.
	SUBSTANTIALLY EQUIVALENT	2
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	2
SOMATEX MEDICAL TECHNOLOGIES GMBH
	SUBSTANTIALLY EQUIVALENT	1
SURGMARK GMBH
	SUBSTANTIALLY EQUIVALENT	1
VIEW POINT MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	232	232
Migration	27	27
Use of Device Problem	27	27
Patient-Device Incompatibility	27	27
Detachment of Device or Device Component	20	20
Break	13	13
Positioning Failure	13	13
Activation, Positioning or Separation Problem	12	12
Device Markings/Labelling Problem	12	12
Difficult to Remove	12	12
Device Contamination with Chemical or Other Material	9	9
Component Missing	9	9
Separation Failure	8	8
Patient Device Interaction Problem	8	8
Activation Problem	7	7
Poor Quality Image	7	7
Entrapment of Device	6	6
Mechanical Problem	6	6
Migration or Expulsion of Device	6	6
Incorrect Measurement	6	6
Material Fragmentation	6	6
Therapeutic or Diagnostic Output Failure	6	6
Component Misassembled	5	5
Retraction Problem	5	5
Material Split, Cut or Torn	5	5
Appropriate Term/Code Not Available	4	4
Device Damaged by Another Device	4	4
Material Twisted/Bent	4	4
Difficult to Insert	4	4
Insufficient Information	4	4
Output Problem	4	4
Expiration Date Error	3	3
Incorrect, Inadequate or Imprecise Result or Readings	3	3
Improper or Incorrect Procedure or Method	3	3
Unable to Obtain Readings	3	3
Failure to Advance	3	3
Fracture	3	3
Device Slipped	3	3
Component or Accessory Incompatibility	3	3
Defective Device	2	2
Positioning Problem	2	2
Premature Activation	2	2
Unexpected Therapeutic Results	2	2
Material Discolored	2	2
Device Appears to Trigger Rejection	2	2
Failure to Eject	2	2
Difficult or Delayed Activation	2	2
Thermal Decomposition of Device	2	2
Malposition of Device	2	2
Audible Prompt/Feedback Problem	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	158	158
Breast Discomfort/Pain	124	124
Foreign Body In Patient	52	52
Sleep Dysfunction	39	39
Erythema	35	35
Pain	33	33
Hypersensitivity/Allergic reaction	30	30
Hematoma	29	29
No Consequences Or Impact To Patient	25	25
Swelling/ Edema	22	22
Itching Sensation	19	19
Unspecified Infection	16	16
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	15	15
Insufficient Information	15	15
Bacterial Infection	14	14
Failure of Implant	13	13
No Known Impact Or Consequence To Patient	13	13
Bruise/Contusion	12	12
Necrosis	11	11
Seroma	11	11
Hemorrhage/Bleeding	10	10
Inflammation	10	10
Device Embedded In Tissue or Plaque	9	9
Deformity/ Disfigurement	9	9
Patient Problem/Medical Problem	9	9
Burning Sensation	9	9
Foreign Body Reaction	8	8
Reaction	7	7
Implant Pain	7	7
Erosion	6	6
Discomfort	6	6
Post Operative Wound Infection	6	6
Scar Tissue	5	5
No Patient Involvement	5	5
Fistula	4	4
Unspecified Tissue Injury	4	4
Abscess	4	4
Rash	4	4
Abdominal Pain	4	4
Local Reaction	4	4
Purulent Discharge	4	4
Pancreatitis	4	4
Post Traumatic Wound Infection	3	3
Fever	3	3
Impaired Healing	3	3
Swollen Lymph Nodes/Glands	3	3
Skin Erosion	3	3
Swelling	3	3
No Code Available	3	3
Wound Dehiscence	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	Hologic, Inc	I	May-03-2024
4	Hologic, Inc	II	Sep-30-2022