TPLC - Total Product Life Cycle

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Device	polymer, ear, nose and throat, synthetic, absorbable
Regulation Description	Ear, nose, and throat synthetic polymer material.
Definition	Ear, nose, and throat absorbable synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is shaped and formed by the surgeon to conform to the patient's needs. This generic type of device is made of absorbable synthetic polymer materials.
Product Code	NHB
Regulation Number	874.3620
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Patient Device Interaction Problem	26	30
Adverse Event Without Identified Device or Use Problem	20	20
Expulsion	7	7
Migration	6	6
Patient-Device Incompatibility	3	3
Fracture	3	3
Packaging Problem	2	2
Tear, Rip or Hole in Device Packaging	2	2
Improper or Incorrect Procedure or Method	2	2
Break	1	1
Migration or Expulsion of Device	1	1
Expiration Date Error	1	1
Difficult to Insert	1	1
Use of Device Problem	1	1
Device Handling Problem	1	1
Detachment of Device or Device Component	1	1
Material Protrusion/Extrusion	1	1
Device Dislodged or Dislocated	1	1
Appropriate Term/Code Not Available	1	1
Device Appears to Trigger Rejection	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	19	23
Pain	10	10
Subcutaneous Nodule	8	8
Failure of Implant	7	11
Swelling/ Edema	7	7
Inflammation	7	7
Obstruction/Occlusion	7	7
Hematoma	6	6
Discomfort	6	10
Visual Disturbances	6	6
Pocket Erosion	5	5
Implant Pain	5	5
Deformity/ Disfigurement	4	4
Scar Tissue	4	4
Insufficient Information	4	4
Bacterial Infection	2	2
Cerebrospinal Fluid Leakage	2	2
Unspecified Tissue Injury	2	2
Eye Injury	2	2
Abscess	2	2
Visual Impairment	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Skin Infection	2	2
Impaired Healing	2	2
Unspecified Infection	2	2
Seroma	1	1
Skin Discoloration	1	1
Foreign Body Reaction	1	1
Cellulitis	1	1
Itching Sensation	1	1
Cyst(s)	1	1
Adhesion(s)	1	1
Nasal Obstruction	1	1
Calcium Deposits/Calcification	1	1
Necrosis	1	1
Sepsis	1	1
Unspecified Respiratory Problem	1	1
Hemorrhage/Bleeding	1	1
Sleep Dysfunction	1	1
Fibrosis	1	1
Tissue Breakdown	1	1
Bruise/Contusion	1	1