TPLC - Total Product Life Cycle

• Device: tongue suspension system
• Definition: Intended to be used for anterior advancement of the tongue base by means of a bone screw threaded with a suture. It is indicated for the treatment of obstructive sleep apnea (OSA) and/or snoring.
• Product Code: ORY
• Regulation Number: 872.5570
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
SIESTA MEDICAL, INC
	SUBSTANTIALLY EQUIVALENT	1
SIESTA MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2

MDR Year	MDR Reports	MDR Events
2019	2	2
2020	2	2
2022	2	2
2023	20	20
2024	5	5

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	18	18
Break	2	2
Material Fragmentation	2	2
Detachment of Device or Device Component	2	2
Device Dislodged or Dislocated	1	1
Migration or Expulsion of Device	1	1
Inadequacy of Device Shape and/or Size	1	1
Improper or Incorrect Procedure or Method	1	1
Positioning Problem	1	1
Insufficient Information	1	1
Material Split, Cut or Torn	1	1
Lack of Effect	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Apnea	5	5
Unspecified Infection	5	5
Implant Pain	4	4
No Clinical Signs, Symptoms or Conditions	4	4
Post Operative Wound Infection	3	3
Skin Infection	3	3
Speech Disorder	2	2
Discomfort	2	2
Deformity/ Disfigurement	1	1
Inadequate Pain Relief	1	1
Neck Pain	1	1
Dysphagia/ Odynophagia	1	1
Emotional Changes	1	1
Headache	1	1
Hearing Impairment	1	1
Failure of Implant	1	1
Paresthesia	1	1
Difficulty Chewing	1	1
Patient Problem/Medical Problem	1	1
Pain	1	1
Paresis	1	1