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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 4
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 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 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 3
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
SURGENTEC, LLC
  SUBSTANTIALLY EQUIVALENT 2
VENTRIS MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 4
XENCO MEDICAL, LLC
  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 15 15

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 244 244
Insufficient Information 63 63
Break 32 32
Fracture 27 27
Migration 22 22
Failure to Eject 18 18
Migration or Expulsion of Device 17 17
Chemical Problem 13 13
Appropriate Term/Code Not Available 11 11
Patient-Device Incompatibility 7 7
Device Difficult to Setup or Prepare 7 7
Fluid/Blood Leak 4 4
Improper or Incorrect Procedure or Method 4 4
Use of Device Problem 4 4
Tear, Rip or Hole in Device Packaging 4 4
Patient Device Interaction Problem 4 4
No Apparent Adverse Event 4 4
Device Dislodged or Dislocated 4 4
Coagulation in Device or Device Ingredient 3 3
Crack 3 3
Contamination 2 2
Material Too Rigid or Stiff 2 2
Defective Device 2 2
Contamination of Device Ingredient or Reagent 2 2
Material Integrity Problem 2 2
Osseointegration Problem 2 2
Difficult to Open or Remove Packaging Material 2 2
Material Too Soft/Flexible 1 1
Output Problem 1 1
Packaging Problem 1 1
Material Protrusion/Extrusion 1 1
Human-Device Interface Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Device Ingredient or Reagent Problem 1 1
Device Markings/Labelling Problem 1 1
Malposition of Device 1 1
Expiration Date Error 1 1
Failure to Osseointegrate 1 1
Defective Component 1 1
Microbial Contamination of Device 1 1
Inaccurate Delivery 1 1
Material Separation 1 1
Inadequacy of Device Shape and/or Size 1 1
Unstable 1 1
Off-Label Use 1 1
Nonstandard Device 1 1
Unintended Ejection 1 1
Difficult to Insert 1 1
Leak/Splash 1 1
Loose or Intermittent Connection 1 1
Mechanical Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 71 71
Unspecified Infection 65 65
No Clinical Signs, Symptoms or Conditions 62 62
Non-union Bone Fracture 31 31
Hematoma 29 29
Injury 27 27
Swelling/ Edema 27 27
No Code Available 25 25
Insufficient Information 24 24
Post Operative Wound Infection 21 21
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 16 16
Skin Discoloration 16 16
Swelling 16 16
No Consequences Or Impact To Patient 14 14
No Known Impact Or Consequence To Patient 14 14
Unspecified Tissue Injury 13 13
Failure of Implant 13 13
Bone Fracture(s) 13 13
Arthritis 9 9
Erythema 8 8
Nerve Damage 8 8
Impaired Healing 7 7
Wound Dehiscence 7 7
Fluid Discharge 7 7
Death 6 6
Seroma 6 6
Weakness 5 5
Cerebrospinal Fluid Leakage 5 5
Inflammation 5 5
Ambulation Difficulties 5 5
Skin Infection 5 5
Foreign Body In Patient 4 4
Osteolysis 4 4
Hypersensitivity/Allergic reaction 4 4
Embolism 4 4
Cyst(s) 4 4
Bacterial Infection 4 4
Numbness 4 4
Necrosis 4 4
Neurological Deficit/Dysfunction 3 3
Itching Sensation 3 3
Joint Dislocation 3 3
Tingling 3 3
Depression 3 3
Bruise/Contusion 3 3
Dysphagia/ Odynophagia 3 3
Headache 3 3
Incontinence 3 3
Infiltration into Tissue 3 3
Joint Laxity 3 3
Implant Pain 3 3
No Information 3 3
Skin Inflammation/ Irritation 2 2
Eczema 2 2
Thrombosis/Thrombus 2 2
Decreased Sensitivity 2 2
Test Result 2 2
Unspecified Respiratory Problem 2 2
Fatigue 2 2
Emotional Changes 2 2
Autoimmune Disorder 2 2
Pulmonary Embolism 2 2
Fungal Infection 2 2
Reaction 2 2
Neuropathy 2 2
Paralysis 2 2
Loss of Range of Motion 2 2
Local Reaction 1 1
Renal Failure 1 1
Pneumonia 1 1
Necrosis Of Flap Tissue 1 1
Spinal Column Injury 1 1
Urinary Retention 1 1
Urinary Tract Infection 1 1
Vomiting 1 1
Burning Sensation 1 1
Hypoesthesia 1 1
Myalgia 1 1
Therapeutic Response, Decreased 1 1
Ulcer 1 1
Abscess 1 1
Ossification 1 1
Bradycardia 1 1
Dyspnea 1 1
Purulent Discharge 1 1
Cardiopulmonary Arrest 1 1
Stroke/CVA 1 1
Fall 1 1
Fever 1 1
Fistula 1 1
Iritis 1 1
Irritation 1 1
Low Blood Pressure/ Hypotension 1 1
Unspecified Hepatic or Biliary Problem 1 1
Renal Impairment 1 1
Vertebral Fracture 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Fibrosis 1 1
Missing Value Reason 1 1
Unspecified Immune System Problem 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 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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