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	23	23
Break	3	3
Insufficient Information	3	3
Material Fragmentation	2	2
Detachment of Device or Device Component	2	2
Lack of Effect	2	2
Improper or Incorrect Procedure or Method	1	1
Material Split, Cut or Torn	1	1
Migration or Expulsion of Device	1	1

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