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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cement, bone, vertebroplasty
Product CodeNDN
Regulation Number 888.3027
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOPSYBELL S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
BONWRX LTD
  SUBSTANTIALLY EQUIVALENT 1
DEPUY SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
GS MEDICAL CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
GS MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HYPREVENTION
  SUBSTANTIALLY EQUIVALENT 1
HYPREVENTION SAS
  SUBSTANTIALLY EQUIVALENT 1
JOLINE GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
NINGBO HICREN BIOTECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SLK ORTHO LLC
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
STRYKER INSTRUMENTS
  SUBSTANTIALLY EQUIVALENT 2
TECRES S.P.A.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 227 227
2020 212 212
2021 344 344
2022 270 271
2023 311 315
2024 121 121

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 230 230
Improper Chemical Reaction 195 195
Leak/Splash 171 171
Chemical Problem 151 151
Migration or Expulsion of Device 142 142
Fluid/Blood Leak 133 133
Material Integrity Problem 92 92
Failure to Eject 87 87
Migration 81 81
Inflation Problem 66 66
Break 55 55
Coagulation in Device or Device Ingredient 25 25
Appropriate Term/Code Not Available 23 23
No Apparent Adverse Event 18 18
Fracture 18 20
Compatibility Problem 16 16
Entrapment of Device 14 14
Packaging Problem 12 12
Insufficient Information 11 11
Activation Failure 10 11
Difficult or Delayed Separation 10 12
Activation, Positioning or Separation Problem 10 10
Separation Failure 9 9
Device-Device Incompatibility 5 5
Device Handling Problem 5 5
Difficult to Remove 5 5
Crack 5 5
Clumping in Device or Device Ingredient 4 4
Mechanical Problem 4 4
Use of Device Problem 4 4
Improper or Incorrect Procedure or Method 4 4
Patient Device Interaction Problem 4 4
Device Difficult to Maintain 4 4
Pressure Problem 3 3
Device Damaged Prior to Use 3 3
Product Quality Problem 3 3
Tear, Rip or Hole in Device Packaging 3 3
Expiration Date Error 3 3
Device Difficult to Setup or Prepare 3 3
Excess Flow or Over-Infusion 3 3
Deflation Problem 3 3
Material Rupture 2 2
Material Separation 2 2
Mechanics Altered 2 2
Inaccurate Information 2 2
Detachment of Device or Device Component 2 2
Device Ingredient or Reagent Problem 1 1
Difficult to Open or Close 1 1
Device Dislodged or Dislocated 1 1
Patient-Device Incompatibility 1 1
Biocompatibility 1 1
Contamination /Decontamination Problem 1 1
Component or Accessory Incompatibility 1 1
Positioning Problem 1 1
Osseointegration Problem 1 1
Output Problem 1 1
Mechanical Jam 1 1
Short Fill 1 1
Problem with Sterilization 1 1
Off-Label Use 1 1
Misassembled 1 1
Nonstandard Device 1 1
Component Missing 1 1
Failure to Discharge 1 1
Material Discolored 1 1
Backflow 1 1
Loss of or Failure to Bond 1 1
Material Fragmentation 1 1
Use of Incorrect Control/Treatment Settings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 727 732
Extravasation 132 132
No Known Impact Or Consequence To Patient 110 110
No Consequences Or Impact To Patient 104 104
Insufficient Information 83 84
Pain 58 58
Bone Fracture(s) 58 58
No Code Available 52 52
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 37 37
Nerve Damage 37 37
Foreign Body In Patient 30 30
Unspecified Tissue Injury 27 27
Pulmonary Embolism 25 25
Non-union Bone Fracture 23 23
Osteolysis 22 22
Hematoma 22 22
Post Operative Wound Infection 22 22
Failure of Implant 20 20
Unspecified Infection 18 18
Joint Laxity 17 17
Injury 16 16
Embolism/Embolus 14 14
Decreased Sensitivity 10 10
No Patient Involvement 9 9
Spinal Cord Injury 9 9
Vertebral Fracture 9 9
Perforation of Vessels 9 9
Cardiac Arrest 9 9
Dyspnea 9 9
Death 8 8
Cerebrospinal Fluid Leakage 8 8
Arrhythmia 7 7
Necrosis 7 7
Paralysis 7 7
Weakness 6 6
Stenosis 6 6
Chest Pain 6 6
Device Embedded In Tissue or Plaque 6 6
Neck Pain 5 5
Physical Asymmetry 5 5
Hypersensitivity/Allergic reaction 5 5
Impaired Healing 5 5
Pneumonia 4 4
Neurological Deficit/Dysfunction 4 4
Dysphagia/ Odynophagia 4 4
Swelling/ Edema 4 4
Ambulation Difficulties 4 4
Paraplegia 3 3
Pleural Effusion 3 3
Thrombosis/Thrombus 3 3
Unspecified Nervous System Problem 3 3
Cancer 3 3
Low Blood Pressure/ Hypotension 3 3
Inflammation 3 3
Muscle Weakness 3 3
Loss of Range of Motion 3 3
Numbness 3 3
Paresis 2 2
Spinal Column Injury 2 2
Tissue Damage 2 2
Myocardial Infarction 2 2
Hypoxia 2 2
Fever 2 2
Hemorrhage/Bleeding 2 2
Edema 2 2
Stroke/CVA 2 2
Wound Dehiscence 2 2
Bacterial Infection 2 2
Adult Respiratory Distress Syndrome 2 2
Speech Disorder 2 2
Ischemia Stroke 2 2
Foreign Body Embolism 2 2
Thromboembolism 2 2
Not Applicable 2 2
Blood Loss 2 2
Sudden Cardiac Death 2 2
Implant Pain 2 2
Cardiac Perforation 1 1
Sleep Dysfunction 1 1
Pseudoaneurysm 1 1
Respiratory Failure 1 1
Fluid Discharge 1 1
Osteopenia/ Osteoporosis 1 1
Tricuspid Valve Insufficiency/ Regurgitation 1 1
Intervertebral Disc Compression or Protrusion 1 1
Unspecified Musculoskeletal problem 1 1
Paresthesia 1 1
Convulsion/Seizure 1 1
Peripheral Nervous Injury 1 1
Anaphylactic Shock 1 1
Anemia 1 1
Aspiration/Inhalation 1 1
Cyst(s) 1 1
Hemoptysis 1 1
Headache 1 1
Fall 1 1
Fatigue 1 1
High Blood Pressure/ Hypertension 1 1
Ischemia 1 1
Laceration(s) 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Howmedica Osteonics Corp. II May-05-2020
2 Stryker Spine II Jul-20-2021
3 TEKNIMED SAS II Feb-06-2023
4 Zavation II Jun-01-2021
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