TPLC - Total Product Life Cycle

• Device: splint, intranasal septal
• Regulation Description: Intranasal splint.
• Product Code: LYA
• Regulation Number: 874.4780
• Device Class: 1

Premarket Reviews
Manufacturer	Decision
BIOMED ENT, INC.
	SUBSTANTIALLY EQUIVALENT	1
SPIRAIR, INC.
	SUBSTANTIALLY EQUIVALENT	1
SPIWAY, LLC
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2021	19	19
2022	8	8
2023	17	17
2024	7	7
2025	1	1
2026	1	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	19	19
Material Integrity Problem	11	11
Tear, Rip or Hole in Device Packaging	5	5
Migration or Expulsion of Device	3	3
Use of Device Problem	3	3
Material Too Rigid or Stiff	2	2
Packaging Problem	2	2
Contamination of Device Ingredient or Reagent	2	2
Device Dislodged or Dislocated	2	2
Unexpected Therapeutic Results	2	2
Patient-Device Incompatibility	1	1
Unsealed Device Packaging	1	1
Microbial Contamination of Device	1	1
Material Discolored	1	1
Delivered as Unsterile Product	1	1
Labelling, Instructions for Use or Training Problem	1	1
Inadequacy of Device Shape and/or Size	1	1
Device Contamination with Chemical or Other Material	1	1
Melted	1	1
Nonstandard Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	13	13
No Clinical Signs, Symptoms or Conditions	12	12
Headache	12	12
Swelling/ Edema	7	7
Post Traumatic Wound Infection	4	4
Hemorrhage/Bleeding	4	4
Unspecified Infection	3	3
Unspecified Tissue Injury	3	3
Respiratory Insufficiency	3	3
Inflammation	2	2
Epistaxis	2	2
Bacterial Infection	2	2
Skin Infection	1	1
Fungal Infection	1	1
Necrosis	1	1
Adhesion(s)	1	1
Hematoma	1	1
Perforation	1	1
Scarring	1	1
Cellulitis	1	1
Post Operative Wound Infection	1	1
Seroma	1	1
Foreign Body In Patient	1	1
Scar Tissue	1	1
Prolapse	1	1
Therapeutic Response, Decreased	1	1
Deformity/ Disfigurement	1	1
Eye Pain	1	1
Granuloma	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	GELITA MEDICAL GMBH	II	Sep-19-2022