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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device platelet and plasma separator for bone graft handling
Definition Preparation of autologous platelet rich plasma from a small sample of peripheral blood for mixing with bone graft to improve handling characteristics.
Product CodeORG
Regulation Number 864.9245
Device Class 2


Premarket Reviews
ManufacturerDecision
AEON BIOTHERAPEUTICS CORP.
  SUBSTANTIALLY EQUIVALENT 2
APEX BIOLOGIX
  SUBSTANTIALLY EQUIVALENT 1
ARTERIOCYTE MEDICAL SYSTEMS, INC
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 5
BIOMET BIOLOGICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
EMCYTE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
FIDIA FARMACEUTICI S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
GENESIS BIOLOGICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
HAELEON MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
HOLDING TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
LUVO MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
RANFAC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
REAPPLIX APS
  SUBSTANTIALLY EQUIVALENT 1
ROYAL BIOLOGICS INC
  SUBSTANTIALLY EQUIVALENT 2
SUNEVA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
TERUMO BCT, INC
  SUBSTANTIALLY EQUIVALENT 1
YTS GLOBAL INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 11 11
2020 20 20
2021 25 25
2022 25 25
2023 83 83
2024 27 27

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 38 38
Defective Device 29 29
Leak/Splash 26 26
Material Puncture/Hole 13 13
Break 10 10
Use of Device Problem 8 8
Output Problem 8 8
Off-Label Use 6 6
Smoking 5 5
Insufficient Flow or Under Infusion 5 5
Device Emits Odor 5 5
Display or Visual Feedback Problem 5 5
Mechanical Problem 4 4
Fitting Problem 4 4
Obstruction of Flow 4 4
Device Handling Problem 3 3
Volume Accuracy Problem 3 3
Improper or Incorrect Procedure or Method 3 3
Coagulation in Device or Device Ingredient 3 3
Crack 2 2
Disconnection 2 2
Burst Container or Vessel 2 2
Difficult to Insert 2 2
Defective Component 2 2
Overheating of Device 2 2
Noise, Audible 2 2
Explosion 2 2
Unexpected Shutdown 2 2
Difficult or Delayed Separation 2 2
Infusion or Flow Problem 2 2
No Flow 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Component Missing 2 2
Expiration Date Error 2 2
Detachment of Device or Device Component 2 2
Device Markings/Labelling Problem 2 2
Patient-Device Incompatibility 2 2
Improper Flow or Infusion 2 2
Inadequate User Interface 1 1
Calibration Problem 1 1
Connection Problem 1 1
Failure to Auto Stop 1 1
Failure to Shut Off 1 1
Gas/Air Leak 1 1
Device Displays Incorrect Message 1 1
Device Contamination with Body Fluid 1 1
Structural Problem 1 1
Output below Specifications 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Protective Measures Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Appropriate Term/Code Not Available 1 1
Air/Gas in Device 1 1
Wrong Label 1 1
Failure to Eject 1 1
Patient Device Interaction Problem 1 1
Peeled/Delaminated 1 1
Device Difficult to Setup or Prepare 1 1
Increase in Pressure 1 1
No Device Output 1 1
Difficult to Remove 1 1
Failure to Sense 1 1
Microbial Contamination of Device 1 1
Problem with Sterilization 1 1
Excess Flow or Over-Infusion 1 1
Misconnection 1 1
Nonstandard Device 1 1
Loose or Intermittent Connection 1 1
Defective Alarm 1 1
Backflow 1 1
Contamination 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 92 92
Insufficient Information 57 57
No Known Impact Or Consequence To Patient 17 17
Exposure to Body Fluids 10 10
Swelling/ Edema 7 7
Unspecified Infection 2 2
Inflammation 2 2
No Code Available 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Pain 2 2
No Consequences Or Impact To Patient 1 1
Blood Loss 1 1
Syncope/Fainting 1 1
Osteomyelitis 1 1
Subcutaneous Nodule 1 1
Nodule 1 1
Reaction to Medicinal Component of Device 1 1
Laceration(s) 1 1
Autoimmune Reaction 1 1
Bacterial Infection 1 1
Erythema 1 1
Fever 1 1
Hair Loss 1 1
Hypersensitivity/Allergic reaction 1 1
Failure of Implant 1 1

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