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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
ANIKA THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
ANIKA THERAPEUTICS. INC.
  SUBSTANTIALLY EQUIVALENT 2
ARTOSS GMBH
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
BIOCOMPOSITES LTD
  SUBSTANTIALLY EQUIVALENT 1
BIOGENNIX, LLC
  SUBSTANTIALLY EQUIVALENT 2
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 2
COLLAGEN MATRIX, INC.
  SUBSTANTIALLY EQUIVALENT 4
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
GEISTLICH PHARMA AG
  SUBSTANTIALLY EQUIVALENT 1
GRAFTYS
  SUBSTANTIALLY EQUIVALENT 1
INION OY
  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
NOVABONE PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 1
NUVASIVE, INC.
  SUBSTANTIALLY EQUIVALENT 1
NUVASIVE, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
ORTHOCON INC.
  SUBSTANTIALLY EQUIVALENT 1
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 2
VENTRIS MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 4
XENCO MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
XEROTHERA INC
  SUBSTANTIALLY EQUIVALENT 1
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
2019 65 65
2020 126 126
2021 101 101
2022 47 47
2023 120 120
2024 52 52

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 262 262
Insufficient Information 68 68
Break 33 33
Fracture 27 27
Migration 27 27
Failure to Eject 18 18
Migration or Expulsion of Device 17 17
Chemical Problem 13 13
Appropriate Term/Code Not Available 11 11
Device Dislodged or Dislocated 8 8
Patient-Device Incompatibility 8 8
Device Difficult to Setup or Prepare 7 7
Tear, Rip or Hole in Device Packaging 5 5
Patient Device Interaction Problem 5 5
Fluid/Blood Leak 4 4
No Apparent Adverse Event 4 4
Use of Device Problem 4 4
Improper or Incorrect Procedure or Method 4 4
Coagulation in Device or Device Ingredient 3 3
Crack 3 3
Osseointegration Problem 2 2
Off-Label Use 2 2
Material Integrity Problem 2 2
Difficult to Open or Remove Packaging Material 2 2
Contamination 2 2
Defective Device 2 2
Material Too Rigid or Stiff 2 2
Contamination of Device Ingredient or Reagent 2 2
Activation, Positioning or Separation Problem 2 2
Material Too Soft/Flexible 1 1
Loose or Intermittent Connection 1 1
Human-Device Interface Problem 1 1
Nonstandard Device 1 1
Defective Component 1 1
Output Problem 1 1
Malposition of Device 1 1
Mechanical Problem 1 1
Microbial Contamination of Device 1 1
Difficult to Insert 1 1
Expiration Date Error 1 1
Unintended Ejection 1 1
Failure to Osseointegrate 1 1
Packaging Problem 1 1
Inadequacy of Device Shape and/or Size 1 1
Material Separation 1 1
Device Markings/Labelling Problem 1 1
Material Protrusion/Extrusion 1 1
Unstable 1 1
Device Ingredient or Reagent Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 73 73
Pain 72 72
No Clinical Signs, Symptoms or Conditions 68 68
Non-union Bone Fracture 31 31
Post Operative Wound Infection 29 29
Hematoma 29 29
Swelling/ Edema 28 28
Injury 27 27
No Code Available 25 25
Insufficient Information 24 24
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 18 18
Bone Fracture(s) 17 17
Swelling 16 16
Skin Discoloration 16 16
No Known Impact Or Consequence To Patient 14 14
No Consequences Or Impact To Patient 14 14
Unspecified Tissue Injury 13 13
Failure of Implant 13 13
Wound Dehiscence 12 12
Arthritis 9 9
Inflammation 9 9
Erythema 8 8
Nerve Damage 8 8
Infiltration into Tissue 7 7
Fluid Discharge 7 7
Impaired Healing 7 7
Death 6 6
Seroma 6 6
Cerebrospinal Fluid Leakage 5 5
Implant Pain 5 5
Skin Infection 5 5
Weakness 5 5
Ambulation Difficulties 5 5
Cyst(s) 4 4
Bacterial Infection 4 4
Necrosis 4 4
Embolism 4 4
Hypersensitivity/Allergic reaction 4 4
Numbness 4 4
Osteolysis 4 4
Foreign Body In Patient 4 4
No Information 3 3
Headache 3 3
Itching Sensation 3 3
Joint Laxity 3 3
Dysphagia/ Odynophagia 3 3
Joint Dislocation 3 3
Tingling 3 3
Incontinence 3 3
Neurological Deficit/Dysfunction 3 3

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 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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