TPLC - Total Product Life Cycle

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Device	barrier, animal source, intraoral
Regulation Description	Bone grafting material.
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
SK BIOLAND CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Insufficient Information	51	51
Adverse Event Without Identified Device or Use Problem	13	13
Appropriate Term/Code Not Available	4	4
Material Integrity Problem	3	3
Use of Device Problem	2	2
Failure to Osseointegrate	2	2
Osseointegration Problem	2	2
Device Ingredient or Reagent Problem	1	1
Material Split, Cut or Torn	1	1
Patient-Device Incompatibility	1	1
Therapeutic or Diagnostic Output Failure	1	1
Patient Device Interaction Problem	1	1
Material Discolored	1	1
Biocompatibility	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Failure of Implant	30	30
Inflammation	19	19
Wound Dehiscence	17	17
Unspecified Infection	14	14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	8	8
Pain	7	7
Insufficient Information	6	6
Swelling/ Edema	4	4
Impaired Healing	3	3
Implant Pain	3	3
Hypersensitivity/Allergic reaction	2	2
Post Operative Wound Infection	2	2
Abscess	2	2
Drug Resistant Bacterial Infection	1	1
Inadequate Osseointegration	1	1
No Clinical Signs, Symptoms or Conditions	1	1
Hematoma	1	1
Perforation	1	1
Purulent Discharge	1	1
Foreign Body Reaction	1	1
No Known Impact Or Consequence To Patient	1	1
Hepatitis	1	1
Nerve Damage	1	1
Osteolysis	1	1
Numbness	1	1
Laceration(s)	1	1
Malunion of Bone	1	1
Physical Asymmetry	1	1
Headache	1	1
Tissue Breakdown	1	1
Neuralgia	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Collagen Matrix Inc	II	Jan-29-2020