TPLC - Total Product Life Cycle

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

Premarket Reviews
Manufacturer	Decision
ARTHROCARE CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
BIOMED ENT, INC.
	SUBSTANTIALLY EQUIVALENT	1
CHITOGEL LTD
	SUBSTANTIALLY EQUIVALENT	1
COGENT THERAPEUTICS, LLC
	SUBSTANTIALLY EQUIVALENT	1
ENTRIGUE SURGICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
GYRUS ACMI, INC
	SUBSTANTIALLY EQUIVALENT	1
HEMOSTASIS, LLC
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC XOMED
	SUBSTANTIALLY EQUIVALENT	1
POLYGANICS BV
	SUBSTANTIALLY EQUIVALENT	2
SINEXUS, INC.
	SUBSTANTIALLY EQUIVALENT	1
SPIWAY LLC
	SUBSTANTIALLY EQUIVALENT	2
SPIWAY, LLC
	SUBSTANTIALLY EQUIVALENT	2
STS MEDICAL
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2014	4	4
2015	28	28
2016	28	28
2017	10	10
2018	19	19
2019	5	5
2020	6	6
2021	19	19
2022	8	8
2023	17	17
2024	7	7

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	37	37
Device Operates Differently Than Expected	23	23
Material Integrity Problem	14	14
Packaging Problem	14	14
Insufficient Information	10	10
Patient-Device Incompatibility	8	8
Tear, Rip or Hole in Device Packaging	5	5
Device Contamination with Chemical or Other Material	4	4
Material Fragmentation	3	3
Use of Device Problem	3	3
Migration or Expulsion of Device	3	3
Appropriate Term/Code Not Available	3	3
Device Dislodged or Dislocated	3	3
Material Too Rigid or Stiff	2	2
Improper or Incorrect Procedure or Method	2	2
Device Ingredient or Reagent Problem	2	2
Unexpected Therapeutic Results	2	2
Microbial Contamination of Device	2	2
Residue After Decontamination	2	2
Device Emits Odor	2	2
Activation Failure	2	2
Contamination of Device Ingredient or Reagent	2	2
Biocompatibility	1	1
High Capture Threshold	1	1
Component Falling	1	1
Improper Chemical Reaction	1	1
Coagulation in Device or Device Ingredient	1	1
Melted	1	1
Nonstandard Device	1	1
Over-Sensing	1	1
Inadequacy of Device Shape and/or Size	1	1
Migration	1	1
Labelling, Instructions for Use or Training Problem	1	1
Difficult to Remove	1	1
Contamination /Decontamination Problem	1	1
Unsealed Device Packaging	1	1
Material Disintegration	1	1
Unintended Movement	1	1
Incomplete or Missing Packaging	1	1
Material Frayed	1	1
Obstruction of Flow	1	1
Material Discolored	1	1
Difficult to Insert	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Headache	17	17
No Clinical Signs, Symptoms or Conditions	17	17
Pain	16	16
Unspecified Infection	12	12
Inflammation	10	10
Hemorrhage/Bleeding	8	8
No Code Available	8	8
No Patient Involvement	8	8
No Known Impact Or Consequence To Patient	8	8
Reaction	7	7
Swelling/ Edema	6	6
No Consequences Or Impact To Patient	5	5
Pneumonia	5	5
Complaint, Ill-Defined	4	4
Bacterial Infection	4	4
Post Traumatic Wound Infection	4	4
Low Oxygen Saturation	3	3
Respiratory Insufficiency	3	3
Nausea	3	3
Sepsis	3	3
Unspecified Tissue Injury	3	3
Adhesion(s)	3	3
Scarring	3	3
Injury	3	3
Seroma	3	3
Therapeutic Response, Decreased	2	2
Swelling	2	2
Foreign Body In Patient	2	2
Epistaxis	2	2
Post Operative Wound Infection	2	2
Staphylococcus Aureus	2	2
Blood Loss	2	2
Respiratory Distress	2	2
Confusion/ Disorientation	1	1
Fever	1	1
Irritation	1	1
Visual Disturbances	1	1
Cellulitis	1	1
Obstruction/Occlusion	1	1
Dyspnea	1	1
Fall	1	1
Perforation	1	1
Scar Tissue	1	1
Prolapse	1	1
Failure to Anastomose	1	1
Intraocular Infection	1	1
Hematoma	1	1
Cyst(s)	1	1
Nasal Obstruction	1	1
Host-Tissue Reaction	1	1

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