TPLC - Total Product Life Cycle

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Device	platelet and plasma separator for bone graft handling
Regulation Description	Automated blood cell separator.
Definition	Preparation of autologous platelet rich plasma from a small sample of peripheral blood for mixing with bone graft to improve handling characteristics.
Product Code	ORG
Regulation Number	864.9245
Device Class	2

Premarket Reviews
Manufacturer	Decision
AEON BIOTHERAPEUTICS CORP.
	SUBSTANTIALLY EQUIVALENT	1
ARTERIOCYTE MEDICAL SYSTEMS, INC
	SUBSTANTIALLY EQUIVALENT	1
ARTERIOCYTE MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
ARTHREX, INC.
	SUBSTANTIALLY EQUIVALENT	2
B.T.I BIOTECHNOLOGY INSTITUTE, S.L.
	SUBSTANTIALLY EQUIVALENT	1
BAHIA MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
BIOMET BIOLOGICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
FOREVER LABS, INC
	SUBSTANTIALLY EQUIVALENT	1
GALE FORCE AESTHETICS, LLC.
	SUBSTANTIALLY EQUIVALENT	1
GENESIS BIOLOGICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
LUVO MEDICAL TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
ORTHOASCENT
	SUBSTANTIALLY EQUIVALENT	1
RANFAC CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
REAPPLIX APS
	SUBSTANTIALLY EQUIVALENT	1
RMEDICA CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ROYAL BIOLOGICS INC
	SUBSTANTIALLY EQUIVALENT	2
STEMC BIYOTEKNOLOJI ANONIM SIRKETI
	SUBSTANTIALLY EQUIVALENT	1
SUNPHORIA CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
TERUMO BCT, INC
	SUBSTANTIALLY EQUIVALENT	1
YTS GLOBAL INC
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Defective Device	58	58
Use of Device Problem	36	36
Fluid/Blood Leak	30	30
Leak/Splash	26	26
Output Problem	24	24
Material Puncture/Hole	23	23
Device Emits Odor	16	16
No Flow	14	14
Break	13	13
Separation Failure	10	10
Patient Device Interaction Problem	8	8
Physical Resistance/Sticking	8	8
Positioning Failure	7	7
Insufficient Flow or Under Infusion	7	7
Smoking	6	6
Activation Failure	6	6
Off-Label Use	6	6
Display or Visual Feedback Problem	6	6
Device Alarm System	5	5
Volume Accuracy Problem	5	5
Obstruction of Flow	5	5
Fitting Problem	5	5
Calibration Problem	4	4
False Alarm	4	4
Infusion or Flow Problem	4	4
Unexpected Shutdown	4	4
Improper Flow or Infusion	4	4
Failure to Advance	3	3
Detachment of Device or Device Component	3	3
Mechanical Problem	3	3
Overheating of Device	3	3
Difficult to Insert	3	3
Key or Button Unresponsive/not Working	3	3
Connection Problem	2	2
Difficult or Delayed Separation	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Device Displays Incorrect Message	2	2
No Device Output	2	2
Failure to Power Up	2	2
Air/Gas in Device	2	2
Noise, Audible	2	2
Disconnection	2	2
Therapeutic or Diagnostic Output Failure	2	2
Burst Container or Vessel	2	2
Defective Component	2	2
Failure to Sense	2	2
Crack	2	2
Filling Problem	2	2
Output below Specifications	1	1
Inadequate User Interface	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	227	227
Insufficient Information	123	123
Exposure to Body Fluids	10	10
Swelling/ Edema	8	8
Pain	3	3
Unspecified Infection	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Hypersensitivity/Allergic reaction	2	2
Inflammation	2	2
Needle Stick/Puncture	2	2
Syncope/Fainting	1	1
Injection Site Reaction	1	1
Failure of Implant	1	1
Rupture	1	1
Reaction to Medicinal Component of Device	1	1
Fever	1	1
Osteomyelitis	1	1
Erythema	1	1
Nerve Damage	1	1
Discomfort	1	1
Extravasation	1	1
Nodule	1	1
Bacterial Infection	1	1
Subcutaneous Nodule	1	1