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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 1
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
BONALIVE BIOMATERIALS LTD.
  SUBSTANTIALLY EQUIVALENT 1
BONE SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 2
BONESUPPORT AB
  SUBSTANTIALLY EQUIVALENT 1
CELLUMED CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
COLLAGEN MATRIX, INC.
  SUBSTANTIALLY EQUIVALENT 2
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
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 2
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 1
OSTEONOVUS, INC.
  SUBSTANTIALLY EQUIVALENT 1
PROSIDYAN, INC
  SUBSTANTIALLY EQUIVALENT 3
SEASPINE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SEASPINE ORTHOPEDICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
SIRAKOSS LTD.
  SUBSTANTIALLY EQUIVALENT 1
SURGENTEC, LLC
  SUBSTANTIALLY EQUIVALENT 1
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 35 35

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 239 239
Break 41 41
Fracture 26 26
Migration or Expulsion of Device 20 20
Chemical Problem 20 20
Failure to Eject 20 20
Insufficient Information 13 13
Appropriate Term/Code Not Available 12 12
Migration 12 12
Device Operates Differently Than Expected 11 11
Use of Device Problem 8 8
Patient-Device Incompatibility 7 7
Difficult to Insert 5 5
Improper or Incorrect Procedure or Method 5 5
Fluid/Blood Leak 5 5
Tear, Rip or Hole in Device Packaging 4 4
Device Difficult to Setup or Prepare 4 4
Coagulation in Device or Device Ingredient 3 3
Crack 3 3
No Apparent Adverse Event 3 3
Material Integrity Problem 3 3
Material Protrusion/Extrusion 3 3
Expiration Date Error 3 3
Defective Device 2 2
Malposition of Device 2 2
Contamination of Device Ingredient or Reagent 2 2
Osseointegration Problem 2 2
No Flow 2 2
Contamination 2 2
Loose or Intermittent Connection 2 2
Material Too Rigid or Stiff 2 2
Device Inoperable 2 2
Failure to Advance 2 2
Failure to Deliver 2 2
Difficult to Open or Remove Packaging Material 2 2
Device Dislodged or Dislocated 1 1
Device Contamination with Chemical or Other Material 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
Inaccurate Delivery 1 1
Defective Component 1 1
Microbial Contamination of Device 1 1
Failure to Align 1 1
Unstable 1 1
Failure to Osseointegrate 1 1
Material Separation 1 1
Shelf Life Exceeded 1 1
Inadequacy of Device Shape and/or Size 1 1
Mechanical Problem 1 1
Leak/Splash 1 1
Unintended Ejection 1 1
Patient Device Interaction Problem 1 1
Output Problem 1 1
Packaging Problem 1 1
Device Ingredient or Reagent Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 81 81
No Clinical Signs, Symptoms or Conditions 56 56
Unspecified Infection 39 39
No Known Impact Or Consequence To Patient 35 35
No Code Available 35 35
Injury 27 27
No Consequences Or Impact To Patient 25 25
Non-union Bone Fracture 25 25
Swelling 18 18
Skin Discoloration 16 16
Post Operative Wound Infection 16 16
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 15 15
Bone Fracture(s) 15 15
Failure of Implant 12 12
Unspecified Tissue Injury 12 12
Insufficient Information 9 9
Swelling/ Edema 8 8
Erythema 8 8
Arthritis 8 8
Impaired Healing 8 8
Seroma 6 6
Nerve Damage 6 6
Death 6 6
Fluid Discharge 6 6
Foreign Body In Patient 6 6
Numbness 5 5
No Information 5 5
Hematoma 5 5
Weakness 5 5
Embolism 4 4
Necrosis 4 4
Osteolysis 4 4
Dysphagia/ Odynophagia 4 4
Cerebrospinal Fluid Leakage 4 4
Cyst(s) 4 4
Wound Dehiscence 4 4
Ambulation Difficulties 4 4
No Patient Involvement 3 3
Joint Laxity 3 3
Bruise/Contusion 3 3
Hypersensitivity/Allergic reaction 3 3
Headache 3 3
Incontinence 3 3
Itching Sensation 3 3
Inflammation 3 3
Joint Dislocation 3 3
Reaction 3 3
Depression 3 3
Tingling 3 3
Neurological Deficit/Dysfunction 3 3
Paralysis 3 3
Renal Failure 3 3
Loss of Range of Motion 2 2
Neuropathy 2 2
Rupture 2 2
Bacterial Infection 2 2
Bradycardia 2 2
Pulmonary Embolism 2 2
Fall 2 2
Fatigue 2 2
Fever 2 2
Test Result 2 2
Skin Inflammation/ Irritation 2 2
Eczema 2 2
Fungal Infection 2 2
Decreased Sensitivity 2 2
Patient Problem/Medical Problem 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
Osteopenia/ Osteoporosis 1 1
Confusion/ Disorientation 1 1
Loss of consciousness 1 1
Low Oxygen Saturation 1 1
Sudden Cardiac Death 1 1
Implant Pain 1 1
Reaction to Medicinal Component of Device 1 1
Fibrosis 1 1
Malunion of Bone 1 1
Osteomyelitis 1 1
Fistula 1 1
Edema 1 1
Abscess 1 1
Ossification 1 1
Cardiac Arrest 1 1
Cardiopulmonary Arrest 1 1
Iritis 1 1
Irritation 1 1
Nausea 1 1
Facial Nerve Paralysis 1 1
Low Blood Pressure/ Hypotension 1 1
Hepatitis 1 1
Anaphylactoid 1 1
Myalgia 1 1
Therapeutic Response, Decreased 1 1
Urticaria 1 1
Discomfort 1 1
Electrolyte Imbalance 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 Musculoskeletal Transplant Foundation, Inc. II May-12-2021
6 Osteomed, LLC II May-29-2020
7 Skeletal Kinetics, Llc II Jul-15-2020
8 Synthes USA II Feb-15-2018
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