TPLC - Total Product Life Cycle

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Device	polymer, ear, nose and throat, synthetic, absorbable
Definition	Ear, nose, and throat absorbable synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is shaped and formed by the surgeon to conform to the patient's needs. This generic type of device is made of absorbable synthetic polymer materials.
Product Code	NHB
Regulation Number	874.3620
Device Class	2

Premarket Reviews
Manufacturer	Decision
3-D MATRIX, INC.
	SUBSTANTIALLY EQUIVALENT	1
ENTELLUS MEDICAL, INC. (AKA STRYKER ENT)
	SUBSTANTIALLY EQUIVALENT	1
ETHICON, INC.
	SUBSTANTIALLY EQUIVALENT	1
HEMOSTASIS LLC
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC XOMED
	SUBSTANTIALLY EQUIVALENT	1
SPIRAIR, INC.
	SUBSTANTIALLY EQUIVALENT	2
SPIROX, INC.
	SUBSTANTIALLY EQUIVALENT	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	50	50
Fracture	21	21
Patient Device Interaction Problem	13	17
Break	9	9
Appropriate Term/Code Not Available	8	8
Expulsion	6	6
Migration or Expulsion of Device	5	5
Packaging Problem	4	4
Migration	3	3
Patient-Device Incompatibility	3	3
Detachment of Device or Device Component	2	2
Failure to Advance	2	2
Use of Device Problem	2	2
Improper or Incorrect Procedure or Method	2	2
Device Dislodged or Dislocated	2	2
Sharp Edges	1	1
Activation Problem	1	1
Scratched Material	1	1
Device Handling Problem	1	1
Other (for use when an appropriate device code cannot be identified)	1	1
Tear, Rip or Hole in Device Packaging	1	1
Detachment Of Device Component	1	1
Degraded	1	1
Disassembly	1	1
Expiration Date Error	1	1
Malposition of Device	1	1
Material Separation	1	1
Device Operates Differently Than Expected	1	1
Device Contamination with Chemical or Other Material	1	1
Material Protrusion/Extrusion	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Not Applicable	24	24
Pain	14	14
Unspecified Infection	13	13
No Clinical Signs, Symptoms or Conditions	13	17
No Known Impact Or Consequence To Patient	12	12
No Consequences Or Impact To Patient	12	12
No Code Available	11	11
Inflammation	8	8
Scar Tissue	6	6
Swelling	6	6
Visual Impairment	6	6
Hematoma	6	6
Edema	5	5
Abscess	5	5
Visual Disturbances	5	5
Discomfort	5	9
Obstruction/Occlusion	5	5
Pocket Erosion	4	4
Adhesion(s)	4	4
Bacterial Infection	4	4
Necrosis	3	3
Deformity/ Disfigurement	3	3
Subcutaneous Nodule	3	3
Foreign Body In Patient	3	3
Insufficient Information	2	2
Nasal Obstruction	2	2
No Patient Involvement	2	2
Impaired Healing	2	2
Cellulitis	2	2
Cerebrospinal Fluid Leakage	2	2
Fistula	2	2
Foreign Body Reaction	2	2
Failure of Implant	2	6
Wound Dehiscence	1	1
Hemorrhage/Bleeding	1	1
Hearing Loss	1	1
Erythema	1	1
Eye Injury	1	1
Cyst(s)	1	1
Purulent Discharge	1	1
Erosion	1	1
Bruise/Contusion	1	1
Calcium Deposits/Calcification	1	1
Surgical procedure	1	1
Ulcer	1	1
Staphylococcus Aureus	1	1
Sepsis	1	1
Seroma	1	1
Skin Discoloration	1	1
Device Embedded In Tissue or Plaque	1	1
Fibrosis	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	3-D Matrix, Inc.	II	Mar-10-2022