TPLC - Total Product Life Cycle

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Device	barrier, animal source, intraoral
Definition	An animal source dental barrier is an animal-derived material device, such as collagen, intended to aid in guided tissue/bone regeneration procedures and to act as a stable barrier for the containment of bone graft materials when placed around implants.
Product Code	NPL
Regulation Number	872.3930
Device Class	2

Premarket Reviews
Manufacturer	Decision
AROA BIOSURGERY LTD.
	SUBSTANTIALLY EQUIVALENT	1
BEIJING BIOSIS HEALING BIOLOGICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
COLLAGEN MATRIX, INC.
	SUBSTANTIALLY EQUIVALENT	1
DATUM DENTAL LTD.
	SUBSTANTIALLY EQUIVALENT	1
GEISTLICH PHARMA AG
	SUBSTANTIALLY EQUIVALENT	3
KERECIS
	SUBSTANTIALLY EQUIVALENT	1
KERECIS LIMITED
	SUBSTANTIALLY EQUIVALENT	1
ORTHOCELL LTD
	SUBSTANTIALLY EQUIVALENT	1
PURGO BIOLOGICS INC.
	SUBSTANTIALLY EQUIVALENT	1
SIGMAGRAFT INC.
	SUBSTANTIALLY EQUIVALENT	1
1. K223912 InterCollagen® Guide
SK BIOLAND CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Insufficient Information	40	40
Adverse Event Without Identified Device or Use Problem	26	26
Appropriate Term/Code Not Available	5	5
Material Integrity Problem	3	3
Failure to Osseointegrate	3	3
Material Split, Cut or Torn	2	2
Use of Device Problem	2	2
Osseointegration Problem	2	2
Patient Device Interaction Problem	1	1
Degraded	1	1
Material Discolored	1	1
Biocompatibility	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Wound Dehiscence	27	27
Failure of Implant	26	26
Unspecified Infection	19	19
Inflammation	10	10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	8	8
Pain	6	6
Insufficient Information	5	5
Impaired Healing	3	3
No Code Available	3	3
Implant Pain	3	3
No Known Impact Or Consequence To Patient	3	3
Hypersensitivity/Allergic reaction	2	2
Inadequate Osseointegration	2	2
Abscess	2	2
Swelling/ Edema	2	2
Drug Resistant Bacterial Infection	1	1
No Clinical Signs, Symptoms or Conditions	1	1
No Information	1	1
Hematoma	1	1
Perforation	1	1
Purulent Discharge	1	1
Post Operative Wound Infection	1	1
Hepatitis	1	1
Nerve Damage	1	1
Osteolysis	1	1
Numbness	1	1
Laceration(s)	1	1
Malunion of Bone	1	1
Headache	1	1
Tissue Breakdown	1	1
Neuralgia	1	1