TPLC - Total Product Life Cycle

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Device	bone grafting material, synthetic
Regulation Description	Bone grafting material.
Definition	A synthetic bone grafting material is synthetically-derived device, such as hydroxylapatite, intended to fill, augment, or reconstruct periodontal and or bony defects of the upper or lower jaw.
Product Code	LYC
Regulation Number	872.3930
Device Class	2

Premarket Reviews
Manufacturer	Decision
BONALIVE , LTD.
	SUBSTANTIALLY EQUIVALENT	1
DIMENSION INX CORP.
	SUBSTANTIALLY EQUIVALENT	1
FULL GOLDEN BIOTECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
FULL GOLDEN BIOTECH CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
GC AMERICA, INC.
	SUBSTANTIALLY EQUIVALENT	1
HUDENS BIO CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
OSTEOGENE TECH CORP
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN DAZHOU MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	16	16
Insufficient Device Problem Information	7	7
Product Quality Problem	4	4
Failure to Osseointegrate	3	3
Contamination	1	1
Osseointegration Problem	1	1
Loss of or Failure to Bond	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	13	13
Pain	13	13
Inflammation	10	10
Inadequate Osseointegration	7	7
Wound Dehiscence	6	6
Necrosis	4	4
Foreign Body Reaction	4	4
Sensitivity of Teeth	4	4
Implant Pain	3	3
Hypersensitivity/Allergic reaction	2	2
Failure of Implant	2	2
Insufficient Information	2	2
Swelling/ Edema	2	2
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	2	2
No Clinical Signs, Symptoms or Conditions	1	1
Skin Inflammation/ Irritation	1	1
Fever	1	1
Rash	1	1
Burning Sensation	1	1
Foreign Body In Patient	1	1
Nonunion/Delayed-union Bone Fracture	1	1