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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device filler, bone void, calcium compound
Product CodeMQV
Regulation Number 888.3045
Device Class 2


Premarket Reviews
ManufacturerDecision
ACRO BIOMEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
AGNOVOS HEALTHCARE USA, LLC
  SUBSTANTIALLY EQUIVALENT 2
ANIKA THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
ANIKA THERAPEUTICS. INC.
  SUBSTANTIALLY EQUIVALENT 2
ARTOSS GMBH
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 6
BIOCOMPOSITES LTD
  SUBSTANTIALLY EQUIVALENT 1
BIOGENNIX, LLC
  SUBSTANTIALLY EQUIVALENT 1
BIOGENNIX, LLC.
  SUBSTANTIALLY EQUIVALENT 2
BIOSTONE LTD
  SUBSTANTIALLY EQUIVALENT 1
BIOVENTUS
  SUBSTANTIALLY EQUIVALENT 1
BIOVENTUS LLC
  SUBSTANTIALLY EQUIVALENT 1
BONALIVE BIOMATERIALS LTD.
  SUBSTANTIALLY EQUIVALENT 1
BONALIVE BIOMATERIALS, LTD.
  SUBSTANTIALLY EQUIVALENT 1
BONE SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 3
BONESUPPORT AB
  SUBSTANTIALLY EQUIVALENT 1
CELLUMED CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
COLLAGEN MATRIX, INC.
  SUBSTANTIALLY EQUIVALENT 3
CONVERG ENGINEERING
  SUBSTANTIALLY EQUIVALENT 1
CORLIBER (SHENZHEN) MEDICAL DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CURASAN AG
  SUBSTANTIALLY EQUIVALENT 1
DIMENSIONAL BIOCERAMICS, LLC
  SUBSTANTIALLY EQUIVALENT 2
DIMENSIONAL BIOCERAMICS, LLC.
  SUBSTANTIALLY EQUIVALENT 1
DSM BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ELUTE, INC.
  SUBSTANTIALLY EQUIVALENT 1
ETEX CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
GEISTLICH PHARMA AG
  SUBSTANTIALLY EQUIVALENT 1
GRAFTYS
  SUBSTANTIALLY EQUIVALENT 1
HANS BIOMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
INION OY
  SUBSTANTIALLY EQUIVALENT 1
KENSEY NASH CORPORATION DBA DSM BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 2
KUROS BIOSCIENCES B.V.
  SUBSTANTIALLY EQUIVALENT 6
KUROS BIOSCIENCES BV
  SUBSTANTIALLY EQUIVALENT 2
LINACOL MUH DAN KIM CEV TEK MED ITH IHR SAN VE TIC
  SUBSTANTIALLY EQUIVALENT 1
NUVASIVE, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
ORTHOCON, INC.
  SUBSTANTIALLY EQUIVALENT 3
OSSDSIGN AB
  SUBSTANTIALLY EQUIVALENT 1
OSTEONOVUS, INC.
  SUBSTANTIALLY EQUIVALENT 1
PROSIDYAN, INC
  SUBSTANTIALLY EQUIVALENT 3
SEASPINE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SEASPINE ORTHOPEDICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
SIRAKOSS LTD.
  SUBSTANTIALLY EQUIVALENT 1
SURGENTEC, LLC
  SUBSTANTIALLY EQUIVALENT 2
SYNERGY BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 1
SYNERGY BIOMEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
VENTRIS MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
WILTROM CORPORATION LIMITED
  SUBSTANTIALLY EQUIVALENT 2
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 6
XENCO MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 2
ZAVATION MEDICAL PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 2
ZIMMER BIOMET SPINE INC.
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER KNEE CREATIONS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 85 85
2019 65 65
2020 126 126
2021 101 101
2022 47 47
2023 120 120
2024 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 261 261
Insufficient Information 61 61
Break 42 42
Fracture 27 27
Migration 21 21
Failure to Eject 20 20
Migration or Expulsion of Device 20 20
Chemical Problem 20 20
Appropriate Term/Code Not Available 13 13
Device Operates Differently Than Expected 11 11
Patient-Device Incompatibility 10 10
Use of Device Problem 8 8
Improper or Incorrect Procedure or Method 7 7
Device Difficult to Setup or Prepare 7 7
Difficult to Insert 5 5
Fluid/Blood Leak 5 5
Tear, Rip or Hole in Device Packaging 4 4
No Apparent Adverse Event 4 4
Device Dislodged or Dislocated 4 4
Patient Device Interaction Problem 4 4
Expiration Date Error 3 3
Material Integrity Problem 3 3
Material Protrusion/Extrusion 3 3
Coagulation in Device or Device Ingredient 3 3
Crack 3 3
Contamination 2 2
Loose or Intermittent Connection 2 2
Material Too Rigid or Stiff 2 2
Failure to Advance 2 2
Contamination of Device Ingredient or Reagent 2 2
Failure to Deliver 2 2
Device Inoperable 2 2
No Flow 2 2
Osseointegration Problem 2 2
Defective Device 2 2
Malposition of Device 2 2
Difficult to Open or Remove Packaging Material 2 2
Device Contamination with Chemical or Other Material 1 1
Human-Device Interface Problem 1 1
Improper Chemical Reaction 1 1
Compatibility Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Output Problem 1 1
Packaging Problem 1 1
Material Too Soft/Flexible 1 1
Unstable 1 1
Failure to Osseointegrate 1 1
Inaccurate Delivery 1 1
Defective Component 1 1
Microbial Contamination of Device 1 1
Device Ingredient or Reagent Problem 1 1
Device Markings/Labelling Problem 1 1
Failure to Align 1 1
Material Separation 1 1
Shelf Life Exceeded 1 1
Inadequacy of Device Shape and/or Size 1 1
Off-Label Use 1 1
Nonstandard Device 1 1
Mechanical Problem 1 1
Leak/Splash 1 1
Unintended Ejection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 84 84
Unspecified Infection 75 75
No Clinical Signs, Symptoms or Conditions 62 62
No Known Impact Or Consequence To Patient 35 35
No Code Available 35 35
Non-union Bone Fracture 33 33
Hematoma 29 29
Swelling/ Edema 28 28
Injury 27 27
No Consequences Or Impact To Patient 25 25
Insufficient Information 22 22
Post Operative Wound Infection 19 19
Swelling 18 18
Skin Discoloration 16 16
Bone Fracture(s) 16 16
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 16 16
Failure of Implant 15 15
Unspecified Tissue Injury 13 13
Nerve Damage 10 10
Arthritis 9 9
Erythema 8 8
Impaired Healing 8 8
Wound Dehiscence 7 7
Death 6 6
Seroma 6 6
Inflammation 6 6
Fluid Discharge 6 6
Foreign Body In Patient 6 6
Numbness 5 5
No Information 5 5
Skin Infection 5 5
Weakness 5 5
Cerebrospinal Fluid Leakage 5 5
Cyst(s) 5 5
Dysphagia/ Odynophagia 4 4
Bacterial Infection 4 4
Embolism 4 4
Hypersensitivity/Allergic reaction 4 4
Necrosis 4 4
Osteolysis 4 4
Ambulation Difficulties 4 4
No Patient Involvement 3 3
Reaction 3 3
Depression 3 3
Joint Dislocation 3 3
Decreased Sensitivity 3 3
Joint Laxity 3 3
Implant Pain 3 3
Itching Sensation 3 3
Infiltration into Tissue 3 3
Renal Failure 3 3
Neurological Deficit/Dysfunction 3 3
Paralysis 3 3
Tingling 3 3
Incontinence 3 3
Headache 3 3
Bruise/Contusion 3 3
Bradycardia 2 2
Autoimmune Disorder 2 2
Pulmonary Embolism 2 2
Emotional Changes 2 2
Fall 2 2
Fatigue 2 2
Fever 2 2
Rupture 2 2
Loss of Range of Motion 2 2
Neuropathy 2 2
Skin Inflammation/ Irritation 2 2
Eczema 2 2
Unspecified Respiratory Problem 2 2
Test Result 2 2
Fungal Infection 2 2
Loss of consciousness 1 1
Osteopenia/ Osteoporosis 1 1
Patient Problem/Medical Problem 1 1
Confusion/ Disorientation 1 1
Low Oxygen Saturation 1 1
Sudden Cardiac Death 1 1
Fibrosis 1 1
Missing Value Reason 1 1
Unspecified Immune System Problem 1 1
Thrombosis/Thrombus 1 1
Asystole 1 1
Unspecified Hepatic or Biliary Problem 1 1
Renal Impairment 1 1
Vertebral Fracture 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Malunion of Bone 1 1
Osteomyelitis 1 1
Blister 1 1
Reaction to Medicinal Component of Device 1 1
Local Reaction 1 1
Iritis 1 1
Irritation 1 1
Nausea 1 1
Necrosis Of Flap Tissue 1 1
Anaphylactoid 1 1
Myalgia 1 1
Therapeutic Response, Decreased 1 1
Urticaria 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Biocomposites, Ltd. II Dec-18-2020
2 Bioventus, LLC II Apr-15-2019
3 Exactech, Inc. II May-29-2019
4 Howmedica Osteonics Corp. II Dec-22-2018
5 Medtronic Sofamor Danek USA Inc II Sep-08-2023
6 Musculoskeletal Transplant Foundation, Inc. II Feb-09-2024
7 Musculoskeletal Transplant Foundation, Inc. II Nov-17-2023
8 Musculoskeletal Transplant Foundation, Inc. II May-12-2021
9 Osteomed, LLC II May-29-2020
10 Skeletal Kinetics, Llc II Jul-15-2020
11 Synthes USA II Feb-15-2018
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