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
REGEN LAB USA LLC
	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	59	59
Use of Device Problem	35	35
Leak/Splash	21	21
Device Emits Odor	21	21
Output Problem	20	20
Material Puncture/Hole	17	17
No Flow	14	14
Fluid/Blood Leak	13	13
Separation Failure	10	10
Break	9	9
Overheating of Device	7	7
Insufficient Flow or Under Infusion	7	7
Positioning Failure	7	7
Patient Device Interaction Problem	7	7
Activation Failure	6	6
Smoking	6	6
Off-Label Use	6	6
Device Alarm System	5	5
Physical Resistance/Sticking	5	5
Obstruction of Flow	5	5
Volume Accuracy Problem	5	5
Fitting Problem	4	4
Calibration Problem	4	4
False Alarm	4	4
Infusion or Flow Problem	4	4
Noise, Audible	3	3
Failure to Advance	3	3
Unexpected Shutdown	3	3
Improper Flow or Infusion	3	3
Key or Button Unresponsive/not Working	3	3
No Device Output	2	2
Display or Visual Feedback Problem	2	2
Detachment of Device or Device Component	2	2
Difficult or Delayed Separation	2	2
Mechanical Problem	2	2
Failure to Power Up	2	2
Difficult to Insert	2	2
Failure to Sense	2	2
Filling Problem	2	2
Crack	2	2
Backflow	1	1
Air/Gas in Device	1	1
Component Missing	1	1
Contamination /Decontamination Problem	1	1
Difficult to Remove	1	1
Material Twisted/Bent	1	1
Inaccurate Flow Rate	1	1
Problem with Sterilization	1	1
No Display/Image	1	1
Blocked Connection	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	240	240
Insufficient Information	125	125
Exposure to Body Fluids	10	10
Swelling/ Edema	8	8
Pain	3	3
Unspecified Infection	2	2
Hypersensitivity/Allergic reaction	2	2
Inflammation	2	2
Needle Stick/Puncture	2	2
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	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