TPLC - Total Product Life Cycle

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Device	bone grafting material, synthetic
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
DIMENSION INX CORP.
	SUBSTANTIALLY EQUIVALENT	1
GC AMERICA, INC.
	SUBSTANTIALLY EQUIVALENT	1
GENOSS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
INSTITUT STRAUMANN AG
	SUBSTANTIALLY EQUIVALENT	1
OSTEOGENE TECH CORP
	SUBSTANTIALLY EQUIVALENT	1
REVISIOS BV
	SUBSTANTIALLY EQUIVALENT	1
THE IMPLANTECH INC./SHEFABONE
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Insufficient Information	120	120
Failure to Osseointegrate	32	32
Osseointegration Problem	21	21
Adverse Event Without Identified Device or Use Problem	18	18
Patient-Device Incompatibility	9	9
Device Operates Differently Than Expected	5	5
Product Quality Problem	4	4
Migration or Expulsion of Device	3	3
Appropriate Term/Code Not Available	3	3
Device Emits Odor	3	3
Patient Device Interaction Problem	2	2
Shelf Life Exceeded	2	2
Loss of or Failure to Bond	2	2
Contamination	2	2
Improper or Incorrect Procedure or Method	1	1
Device Appears to Trigger Rejection	1	1
Component Missing	1	1
Device Expiration Issue	1	1
Device Markings/Labelling Problem	1	1
Material Separation	1	1
Loss of Osseointegration	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	122	122
Fibrosis	55	55
Inadequate Osseointegration	24	24
Inflammation	23	23
Pain	23	23
No Information	16	16
Impaired Healing	14	14
Reaction	9	9
Burning Sensation	9	9
Irritation	9	9
Swelling	4	4
Abscess	4	4
Foreign Body Reaction	4	4
No Consequences Or Impact To Patient	4	4
Failure of Implant	4	4
Sensitivity of Teeth	4	4
Fever	3	3
Hypersensitivity/Allergic reaction	3	3
Implant Pain	3	3
No Known Impact Or Consequence To Patient	3	3
Discomfort	2	2
Injury	2	2
Foreign Body In Patient	2	2
Non-union Bone Fracture	2	2
Wound Dehiscence	2	2
Host-Tissue Reaction	2	2
Granuloma	1	1
Bacterial Infection	1	1
Debris, Bone Shedding	1	1
Edema	1	1
Tinnitus	1	1
Tissue Damage	1	1
Necrosis	1	1
Nerve Damage	1	1
Osteolysis	1	1
Numbness	1	1
Hypoesthesia	1	1
Complaint, Ill-Defined	1	1
Dizziness	1	1
Swelling/ Edema	1	1
Insufficient Information	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
No Clinical Signs, Symptoms or Conditions	1	1