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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 1
ACUITIVE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
ANIKA THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
ANIKA THERAPEUTICS. INC.
  SUBSTANTIALLY EQUIVALENT 2
BAXTER HEALTHCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
BIOCOMPOSITES LTD
  SUBSTANTIALLY EQUIVALENT 1
BIOGENNIX, LLC
  SUBSTANTIALLY EQUIVALENT 2
BIOGENNIX, LLC.
  SUBSTANTIALLY EQUIVALENT 1
BIOSTONE LTD
  SUBSTANTIALLY EQUIVALENT 1
BIOVENTUS
  SUBSTANTIALLY EQUIVALENT 1
BIOVENTUS LLC
  SUBSTANTIALLY EQUIVALENT 1
BONALIVE BIOMATERIALS, LTD.
  SUBSTANTIALLY EQUIVALENT 1
BONE SOLUTIONS, INC
  SUBSTANTIALLY EQUIVALENT 1
BONE SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 3
BONESUPPORT AB
  SUBSTANTIALLY EQUIVALENT 2
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
DIMENSIONAL BIOCERAMICS, LLC.
  SUBSTANTIALLY EQUIVALENT 1
DSM BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ETEX CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
GEISTLICH PHARMA AG
  SUBSTANTIALLY EQUIVALENT 1
GRAFTYS
  SUBSTANTIALLY EQUIVALENT 1
KUROS BIOSCIENCES
  SUBSTANTIALLY EQUIVALENT 1
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
MEDTRONIC SOFAMOR DANEK, INC.
  SUBSTANTIALLY EQUIVALENT 1
NORAKER
  SUBSTANTIALLY EQUIVALENT 1
NOVABONE PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 2
NUVASIVE, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOCON INC.
  SUBSTANTIALLY EQUIVALENT 3
ORTHOCON, INC.
  SUBSTANTIALLY EQUIVALENT 4
ORTHOREBIRTH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
OSSDSIGN AB
  SUBSTANTIALLY EQUIVALENT 1
PROSIDYAN, INC
  SUBSTANTIALLY EQUIVALENT 1
SEASPINE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SEASPINE ORTHOPEDICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
SIRAKOSS LTD.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER SPINE
  SUBSTANTIALLY EQUIVALENT 1
SURGENTEC, LLC
  SUBSTANTIALLY EQUIVALENT 3
SYNERGY BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 1
VENTRIS MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 2
XEROTHERA INC
  SUBSTANTIALLY EQUIVALENT 1
ZAVATION MEDICAL PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 2
ZIMMER BIOMET SPINE INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 126 126
2021 101 101
2022 47 47
2023 120 120
2024 68 68

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 226 226
Insufficient Information 69 69
Break 32 32
Fracture 23 23
Migration 21 21
Failure to Eject 18 18
Migration or Expulsion of Device 15 15
Chemical Problem 12 12
Appropriate Term/Code Not Available 11 11
Patient-Device Incompatibility 8 8
Device Dislodged or Dislocated 8 8
Device Difficult to Setup or Prepare 7 7
Patient Device Interaction Problem 6 6
Tear, Rip or Hole in Device Packaging 5 5
Fluid/Blood Leak 4 4
Improper or Incorrect Procedure or Method 4 4
Activation, Positioning or Separation Problem 3 3
Off-Label Use 3 3
Coagulation in Device or Device Ingredient 3 3
Osseointegration Problem 2 2
Material Integrity Problem 2 2
Contamination 2 2
Material Too Rigid or Stiff 2 2
Use of Device Problem 2 2
No Apparent Adverse Event 2 2
Contamination of Device Ingredient or Reagent 2 2
Improper Chemical Reaction 1 1
Material Too Soft/Flexible 1 1
Human-Device Interface Problem 1 1
Nonstandard Device 1 1
Inaccurate Delivery 1 1
Material Protrusion/Extrusion 1 1
Inadequacy of Device Shape and/or Size 1 1
Material Separation 1 1
Packaging Problem 1 1
Failure to Osseointegrate 1 1
Unintended Ejection 1 1
Difficult to Insert 1 1
Defective Device 1 1
Expiration Date Error 1 1
Device Markings/Labelling Problem 1 1
Crack 1 1
Output Problem 1 1
Difficult to Open or Remove Packaging Material 1 1
Malposition of Device 1 1
Mechanical Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Device Ingredient or Reagent Problem 1 1
Unstable 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 69 69
Unspecified Infection 64 64
Pain 64 64
Swelling/ Edema 29 29
Hematoma 29 29
Injury 26 26
Post Operative Wound Infection 26 26
Non-union Bone Fracture 25 25
Insufficient Information 25 25
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 21 21
Bone Fracture(s) 18 18
Skin Discoloration 16 16
No Code Available 15 15
Unspecified Tissue Injury 13 13
Swelling 12 12
Failure of Implant 11 11
Wound Dehiscence 10 10
Nerve Damage 10 10
No Known Impact Or Consequence To Patient 10 10
No Consequences Or Impact To Patient 9 9
Inflammation 9 9
Erythema 8 8
Arthritis 7 7
Infiltration into Tissue 7 7
Fluid Discharge 6 6
Implant Pain 6 6
Ambulation Difficulties 5 5
Cerebrospinal Fluid Leakage 5 5
Seroma 5 5
Weakness 5 5
Impaired Healing 5 5
Skin Infection 5 5
Bacterial Infection 4 4
Cyst(s) 4 4
Foreign Body In Patient 4 4
Hypersensitivity/Allergic reaction 4 4
Osteolysis 4 4
Fever 3 3
No Information 3 3
Joint Dislocation 3 3
Joint Laxity 3 3
Pulmonary Embolism 2 2
Reaction 2 2
Embolism/Embolus 2 2
Eczema 2 2
Autoimmune Disorder 2 2
Decreased Sensitivity 2 2
Paralysis 2 2
Skin Inflammation/ Irritation 2 2
Necrosis 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Biocomposites, Ltd. II Dec-18-2020
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 Osteomed, LLC II May-29-2020
9 Skeletal Kinetics, Llc II Jul-15-2020
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