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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	18	18
Material Integrity Problem	11	11
Tear, Rip or Hole in Device Packaging	5	5
Use of Device Problem	3	3
Migration or Expulsion of Device	3	3
Contamination of Device Ingredient or Reagent	2	2
Device Dislodged or Dislocated	2	2
Packaging Problem	2	2
Material Too Rigid or Stiff	2	2
Unexpected Therapeutic Results	2	2
Patient-Device Incompatibility	1	1
Device Contamination with Chemical or Other Material	1	1
Inadequacy of Device Shape and/or Size	1	1
Microbial Contamination of Device	1	1
Material Discolored	1	1
Labelling, Instructions for Use or Training Problem	1	1
Melted	1	1
Nonstandard Device	1	1
Delivered as Unsterile Product	1	1
Unsealed Device Packaging	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	12	12
Pain	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
Necrosis	1	1
Hematoma	1	1
Perforation	1	1
Adhesion(s)	1	1
Scarring	1	1
Post Operative Wound Infection	1	1
Cellulitis	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