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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
Regulation Description Resorbable calcium salt bone void filler device.
Product CodeMQV
Regulation Number 888.3045
Device Class 2


Premarket Reviews
ManufacturerDecision
ACRO BIOMEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ACUITIVE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
ANIKA THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 3
AUSTIN MEDICAL VENTURES, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BIOCOMPOSITES, LTD.
  SUBSTANTIALLY EQUIVALENT 2
BIOGENNIX, LLC
  SUBSTANTIALLY EQUIVALENT 1
BIOSTONE, LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIOVENTUS, LLC
  SUBSTANTIALLY EQUIVALENT 1
BONALIVE BIOMATERIALS, LTD.
  SUBSTANTIALLY EQUIVALENT 1
BONE SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 5
BONESUPPORT AB
  SUBSTANTIALLY EQUIVALENT 1
COLLAGEN MATRIX, INC.
  SUBSTANTIALLY EQUIVALENT 3
CONVERG ENGINEERING
  SUBSTANTIALLY EQUIVALENT 1
CORLIBER (SHENZHEN) MEDICAL DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DIMENSIONAL BIOCERAMICS, LLC
  SUBSTANTIALLY EQUIVALENT 2
DSM BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ELUTE, INC.
  SUBSTANTIALLY EQUIVALENT 1
ETEX CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
GEISTLICH PHARMA AG
  SUBSTANTIALLY EQUIVALENT 2
GRAFTYS
  SUBSTANTIALLY EQUIVALENT 1
KUROS BIOSCIENCES
  SUBSTANTIALLY EQUIVALENT 1
KUROS BIOSCIENCES B.V
  SUBSTANTIALLY EQUIVALENT 9
MEDTRONIC SOFAMOR DANEK, INC.
  SUBSTANTIALLY EQUIVALENT 2
NORAKER
  SUBSTANTIALLY EQUIVALENT 1
NOVABONE PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 2
NUVASIVE, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOCON, INC.
  SUBSTANTIALLY EQUIVALENT 7
ORTHOREBIRTH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
OSSDSIGN AB
  SUBSTANTIALLY EQUIVALENT 1
PROSIDYAN, INC.
  SUBSTANTIALLY EQUIVALENT 2
RTI SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SEASPINE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SEASPINE ORTHOPEDICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
STRYKER SPINE
  SUBSTANTIALLY EQUIVALENT 1
SURGENTEC, LLC
  SUBSTANTIALLY EQUIVALENT 4
SYNERGY BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 1
VENTRIS MEDICAL
  SUBSTANTIALLY EQUIVALENT 4
WRIGHT MEDICAL TECHNOLOGY, INC. (STRYKER CORPORATION)
  SUBSTANTIALLY EQUIVALENT 1
WRIGHTMEDICALTECHNOLOGYINC
  SUBSTANTIALLY EQUIVALENT 1
XEROTHERA, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZAVATION MEDICAL PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER BIOMET SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 101 101
2022 47 47
2023 120 120
2024 68 68
2025 58 58

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 166 166
Insufficient Information 81 81
Migration 24 24
Failure to Eject 17 17
Migration or Expulsion of Device 13 13
Break 10 10
Appropriate Term/Code Not Available 8 8
Device Dislodged or Dislocated 8 8
Fracture 8 8
Use of Device Problem 8 8
Chemical Problem 7 7
Patient-Device Incompatibility 7 7
Device Difficult to Setup or Prepare 7 7
Patient Device Interaction Problem 6 6
Improper or Incorrect Procedure or Method 5 5
Fluid/Blood Leak 4 4
Tear, Rip or Hole in Device Packaging 4 4
Biocompatibility 3 3
Nonstandard Device 3 3
Coagulation in Device or Device Ingredient 3 3
No Apparent Adverse Event 3 3
Failure to Osseointegrate 3 3
Off-Label Use 3 3
Activation, Positioning or Separation Problem 3 3
Material Too Rigid or Stiff 2 2
Contamination 2 2
Material Integrity Problem 2 2
Contamination of Device Ingredient or Reagent 2 2
Crack 2 2
Device Contaminated During Manufacture or Shipping 2 2
Osseointegration Problem 2 2
Unintended Ejection 1 1
Difficult to Insert 1 1
Degraded 1 1
Lack of Effect 1 1
Use of Incorrect Control/Treatment Settings 1 1
Packaging Problem 1 1
Material Separation 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Defective Device 1 1
Device Markings/Labelling Problem 1 1
Device Damaged Prior to Use 1 1
Inaccurate Delivery 1 1
Output Problem 1 1
Mechanical Problem 1 1
Human-Device Interface Problem 1 1
Material Too Soft/Flexible 1 1
Improper Chemical Reaction 1 1
Device Ingredient or Reagent Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 78 78
Unspecified Infection 62 62
Insufficient Information 37 37
Pain 33 33
Hematoma 28 28
Post Operative Wound Infection 26 26
Non-union Bone Fracture 26 26
Swelling/ Edema 25 25
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 24 24
Bone Fracture(s) 19 19
Skin Discoloration 16 16
Unspecified Tissue Injury 12 12
Wound Dehiscence 11 11
Inflammation 11 11
Nerve Damage 10 10
Implant Pain 9 9
Failure of Implant 7 7
Infiltration into Tissue 7 7
Arthritis 6 6
Skin Infection 5 5
Hypersensitivity/Allergic reaction 5 5
Seroma 5 5
Ambulation Difficulties 4 4
Thrombosis/Thrombus 4 4
Foreign Body In Patient 4 4
Bacterial Infection 4 4
Joint Laxity 4 4
Osteolysis 3 3
Fluid Discharge 3 3
Cyst(s) 3 3
Fever 3 3
Malunion of Bone 3 3
Cerebrospinal Fluid Leakage 3 3
Loss of Range of Motion 2 2
Erythema 2 2
Rash 2 2
Electrolyte Imbalance 2 2
Cardiac Arrest 2 2
Autoimmune Disorder 2 2
Embolism/Embolus 2 2
Unspecified Respiratory Problem 2 2
Skin Inflammation/ Irritation 2 2
Eczema 2 2
Fungal Infection 2 2
Fatigue 2 2
Emotional Changes 2 2
Decreased Sensitivity 2 2
Pulmonary Embolism 2 2
Weight Changes 2 2
Impaired Healing 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Berkeley Advanced Biomaterials, LLC II Nov-18-2025
2 IsoTis OrthoBiologics, Inc. II Jan-16-2025
3 IsoTis OrthoBiologics, Inc. II Jan-15-2025
4 Medtronic Sofamor Danek USA Inc II Sep-08-2023
5 Musculoskeletal Transplant Foundation, Inc. II Feb-09-2024
6 Musculoskeletal Transplant Foundation, Inc. II Nov-17-2023
7 Musculoskeletal Transplant Foundation, Inc. II May-12-2021
8 SCIENCE & BIO MATERIALS II May-02-2025
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