TPLC - Total Product Life Cycle

• 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	4
ELUCENT MEDICAL, INC
	SUBSTANTIALLY EQUIVALENT	1
ENDOMAGNETICS LTD
	SUBSTANTIALLY EQUIVALENT	1
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

MDR Year	MDR Reports	MDR Events
2019	58	58
2020	45	45
2021	82	82
2022	100	100
2023	142	142
2024	57	57

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	181	181
Migration	26	26
Use of Device Problem	25	25
Patient-Device Incompatibility	19	19
Detachment of Device or Device Component	19	19
Positioning Failure	13	13
Break	12	12
Difficult to Remove	12	12
Device Markings/Labelling Problem	12	12
Activation, Positioning or Separation Problem	12	12
Device Contamination with Chemical or Other Material	9	9
Component Missing	9	9
Patient Device Interaction Problem	8	8
Activation Problem	7	7
Poor Quality Image	7	7
Separation Failure	7	7
Therapeutic or Diagnostic Output Failure	6	6
Entrapment of Device	6	6
Material Fragmentation	6	6
Incorrect Measurement	6	6
Mechanical Problem	6	6
Retraction Problem	5	5
Component Misassembled	5	5
Material Split, Cut or Torn	5	5
Material Twisted/Bent	4	4
Output Problem	4	4
Device Damaged by Another Device	4	4
Migration or Expulsion of Device	4	4
Difficult to Insert	4	4
Fracture	3	3
Incorrect, Inadequate or Imprecise Result or Readings	3	3
Unable to Obtain Readings	3	3
Device Slipped	3	3
Failure to Advance	3	3
Expiration Date Error	3	3
Insufficient Information	3	3
Appropriate Term/Code Not Available	3	3
Activation Failure	2	2
Premature Activation	2	2
Tear, Rip or Hole in Device Packaging	2	2
Difficult or Delayed Activation	2	2
Defective Device	2	2
Failure to Fire	2	2
Malposition of Device	2	2
Material Deformation	2	2
Material Protrusion/Extrusion	2	2
Expulsion	2	2
Device-Device Incompatibility	2	2
Positioning Problem	2	2
Failure to Eject	2	2
Audible Prompt/Feedback Problem	2	2
Unexpected Therapeutic Results	2	2
Improper or Incorrect Procedure or Method	2	2
No Audible Prompt/Feedback	2	2
Device Appears to Trigger Rejection	2	2
Thermal Decomposition of Device	2	2
Material Discolored	2	2
Erratic or Intermittent Display	1	1
Electromagnetic Interference	1	1
Electrical /Electronic Property Problem	1	1
Crack	1	1
Degraded	1	1
Image Display Error/Artifact	1	1
Signal Artifact/Noise	1	1
Nonstandard Device	1	1
Failure to Power Up	1	1
Self-Activation or Keying	1	1
Material Separation	1	1
Inaudible or Unclear Audible Prompt/Feedback	1	1
Defective Component	1	1
Failure to Deliver	1	1
Material Perforation	1	1
No Apparent Adverse Event	1	1
Difficult to Advance	1	1
Device Dislodged or Dislocated	1	1
Packaging Problem	1	1
Failure to Form Staple	1	1
Device Sensing Problem	1	1
Device Misassembled During Manufacturing /Shipping	1	1
Chemical Problem	1	1
Communication or Transmission Problem	1	1
Component or Accessory Incompatibility	1	1
Connection Problem	1	1
Poor Visibility	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	145	145
Breast Discomfort/Pain	96	96
Foreign Body In Patient	48	48
Sleep Dysfunction	37	37
Hypersensitivity/Allergic reaction	28	28
Pain	26	26
No Consequences Or Impact To Patient	25	25
Erythema	22	22
Itching Sensation	15	15
No Known Impact Or Consequence To Patient	13	13
Insufficient Information	13	13
Bacterial Infection	12	12
Unspecified Infection	11	11
Hematoma	10	10
Hemorrhage/Bleeding	10	10
Device Embedded In Tissue or Plaque	9	9
Patient Problem/Medical Problem	9	9
Burning Sensation	9	9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	8	8
Reaction	7	7
Failure of Implant	7	7
Necrosis	7	7
Inflammation	6	6
Deformity/ Disfigurement	6	6
No Patient Involvement	5	5
Foreign Body Reaction	5	5
Discomfort	4	4
Seroma	4	4
Swelling/ Edema	4	4
Unspecified Tissue Injury	4	4
Swelling	3	3
No Code Available	3	3
Fistula	3	3
Abdominal Pain	3	3
Abscess	3	3
Scar Tissue	3	3
Rash	2	2
Inadequate Pain Relief	2	2
Burn, Thermal	2	2
Blood Loss	2	2
Bronchospasm	2	2
Weight Changes	2	2
Skin Erosion	2	2
Injury	2	2
Implant Pain	2	2
Unintended Radiation Exposure	2	2
Pancreatitis	2	2
Skin Infection	2	2
Increased Sensitivity	1	1
Cancer Cells Dissemination	1	1
Localized Skin Lesion	1	1
Arthralgia	1	1
Impaired Healing	1	1
Numbness	1	1
Breast Mass	1	1
Post Operative Wound Infection	1	1
Palpitations	1	1
Skin Irritation	1	1
Tinnitus	1	1
Tissue Damage	1	1
Discharge	1	1
Peritonitis	1	1
Urticaria	1	1
Anxiety	1	1
Laceration(s) of Esophagus	1	1
Tissue Breakdown	1	1
Unspecified Mental, Emotional or Behavioural Problem	1	1
Fibrosis	1	1
No Information	1	1
Local Reaction	1	1
Septic Shock	1	1
Neurological Deficit/Dysfunction	1	1
Loss of Range of Motion	1	1
Irritation	1	1
Laceration(s)	1	1
Anemia	1	1
Arthritis	1	1
Asthma	1	1
Calcium Deposits/Calcification	1	1
Purulent Discharge	1	1
Emotional Changes	1	1
Abrasion	1	1
Fatigue	1	1
Fever	1	1
Wound Dehiscence	1	1
Granuloma	1	1
Hair Loss	1	1

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