TPLC - Total Product Life Cycle

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Device	tongue suspension system
Regulation Description	Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.
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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	21	21
Break	3	3
Insufficient Information	2	2
Lack of Effect	2	2
Detachment of Device or Device Component	2	2
Material Fragmentation	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
Material Split, Cut or Torn	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	5	5
Implant Pain	5	5
No Clinical Signs, Symptoms or Conditions	5	5
Discomfort	4	4
Apnea	3	3
Post Operative Wound Infection	3	3
Skin Infection	3	3
Speech Disorder	2	2
Neck Pain	2	2
Choking	2	2
Anemia	1	1
Dysphagia/ Odynophagia	1	1
Emotional Changes	1	1
Headache	1	1
Hearing Impairment	1	1
Hemorrhage/Bleeding	1	1
Failure of Implant	1	1
Patient Problem/Medical Problem	1	1
Paresthesia	1	1
Deformity/ Disfigurement	1	1
Pharyngitis	1	1
Inadequate Pain Relief	1	1
Sore Throat	1	1
Pain	1	1
Paresis	1	1
Seroma	1	1
Difficulty Chewing	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1