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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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Device cement, bone, vertebroplasty
Regulation Description Polymethylmethacrylate (PMMA) bone cement.
Product CodeNDN
Regulation Number 888.3027
Device Class 2


Premarket Reviews
ManufacturerDecision
BONWRX LTD
  SUBSTANTIALLY EQUIVALENT 1
DEPUY SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
DRAGON CROWN MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
G-21 S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
G21 S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
GS MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
  1.  K192335  TRACKER Kyphoplasty System
HANCHANG CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HYPREVENTION SAS
  SUBSTANTIALLY EQUIVALENT 1
IMEDICOM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JOLINE GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC INC
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC SOFAMOR DANEK USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
PAN MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
STRYKER INSTRUMENTS
  SUBSTANTIALLY EQUIVALENT 1
TEKNIMED, SAS
  SUBSTANTIALLY EQUIVALENT 1
VEXIM SA
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 182 182
2017 191 191
2018 144 144
2019 227 227
2020 212 212
2021 231 231

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 183 183
Adverse Event Without Identified Device or Use Problem 181 181
Migration or Expulsion of Device 159 159
Chemical Problem 125 125
Appropriate Term/Code Not Available 99 99
Break 71 71
Migration 64 64
Device Operates Differently Than Expected 49 49
Fluid Leak 43 43
Improper Chemical Reaction 43 43
Failure to Eject 25 25
Coagulation in Device or Device Ingredient 22 22
Material Too Rigid or Stiff 18 18
Fracture 14 14
No Apparent Adverse Event 13 13
Packaging Problem 12 12
Inflation Problem 10 10
Material Integrity Problem 10 10
Use of Device Problem 7 7
Difficult to Remove 7 7
Burst Container or Vessel 6 6
No Flow 6 6
Crack 5 5
Mechanical Problem 5 5
Activation Failure 5 5
Clumping in Device or Device Ingredient 5 5
Device Difficult to Maintain 4 4
Entrapment of Device 4 4
Filling Problem 4 4
Activation, Positioning or SeparationProblem 4 4
Device Difficult to Setup or Prepare 4 4
Difficult to Open or Close 4 4
Deflation Problem 3 3
Positioning Failure 3 3
Delivery System Failure 3 3
Separation Failure 3 3
Patient-Device Incompatibility 3 3
Component Missing 3 3
Material Rupture 3 3
Failure to Advance 3 3
Device-Device Incompatibility 2 2
Pressure Problem 2 2
Improper or Incorrect Procedure or Method 2 2
Fitting Problem 2 2
Difficult to Insert 2 2
Detachment Of Device Component 2 2
Decrease in Pressure 2 2
Product Quality Problem 2 2
Material Separation 2 2
Detachment of Device or Device Component 2 2
Device Expiration Issue 2 2
Excess Flow or Over-Infusion 2 2
Mechanical Jam 2 2
Insufficient Information 2 2
Temperature Problem 1 1
Misassembly by Users 1 1
Output Problem 1 1
Inaccurate Information 1 1
Device Handling Problem 1 1
Patient Device Interaction Problem 1 1
Off-Label Use 1 1
Material Puncture/Hole 1 1
Loss of or Failure to Bond 1 1
Failure to Discharge 1 1
Failure to Cycle 1 1
Use of Incorrect Control Settings 1 1
Component or Accessory Incompatibility 1 1
Defective Device 1 1
Shelf Life Exceeded 1 1
Incomplete or Missing Packaging 1 1
Failure to Align 1 1
Split 1 1
Misassembled 1 1
Delivered as Unsterile Product 1 1
Material Discolored 1 1
Device Damaged Prior to Use 1 1
Tear, Rip or Hole in Device Packaging 1 1
Short Fill 1 1
Sticking 1 1
Unstable 1 1
Physical Resistance/Sticking 1 1
Difficult to Advance 1 1
Extrusion 1 1
Mechanics Altered 1 1
Ambient Temperature Problem 1 1
Biocompatibility 1 1
Contamination /Decontamination Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 419 419
No Clinical Signs, Symptoms or Conditions 151 151
No Consequences Or Impact To Patient 149 149
No Code Available 95 95
Extravasation 89 89
Pain 71 71
Bone Fracture(s) 43 43
Foreign Body In Patient 28 28
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 24 24
Injury 22 22
No Patient Involvement 16 16
Failure of Implant 16 16
Death 15 15
Nerve Damage 14 14
Hematoma 14 14
Pulmonary Embolism 11 11
Device Embedded In Tissue or Plaque 11 11
Non-union Bone Fracture 10 10
Cardiac Arrest 10 10
Inadequate Pain Relief 8 8
Unspecified Tissue Injury 7 7
Unspecified Infection 7 7
Paralysis 7 7
Weakness 6 6
Arrhythmia 6 6
Neurological Deficit/Dysfunction 6 6
Sudden Cardiac Death 6 6
Spinal Cord Injury 5 5
Hypersensitivity/Allergic reaction 5 5
Stenosis 5 5
Post Operative Wound Infection 5 5
Not Applicable 5 5
No Information 5 5
Impaired Healing 4 4
Necrosis 4 4
Anaphylactic Shock 4 4
Embolism 4 4
Dyspnea 4 4
Osteolysis 4 4
Embolism/Embolus 4 4
Physical Asymmetry 3 3
Neuropathy 3 3
Loss of Range of Motion 3 3
Cerebrospinal Fluid Leakage 3 3
Dysphagia/ Odynophagia 3 3
Low Blood Pressure/ Hypotension 3 3
Laceration(s) 3 3
Stroke/CVA 3 3
Chest Pain 3 3
Pleural Effusion 3 3
Pneumonia 3 3
Blood Loss 3 3
Reaction 2 2
Tissue Damage 2 2
Ischemia Stroke 2 2
Pulmonary Infarction 2 2
Discomfort 2 2
Edema 2 2
Hemorrhage/Bleeding 2 2
Inflammation 2 2
Spinal Column Injury 2 2
Respiratory Failure 2 2
Ambulation Difficulties 2 2
Decreased Sensitivity 2 2
Insufficient Information 2 2
Intervertebral Disc Compression or Protrusion 1 1
Convulsion/Seizure 1 1
Paresthesia 1 1
Fluid Discharge 1 1
Osteopenia/ Osteoporosis 1 1
Neck Pain 1 1
Low Oxygen Saturation 1 1
Rash 1 1
Numbness 1 1
Collapse 1 1
Hypoesthesia 1 1
Deformity/ Disfigurement 1 1
Muscle Weakness 1 1
Hepatitis 1 1
Fall 1 1
Wound Dehiscence 1 1
Anemia 1 1
Aspiration/Inhalation 1 1
Burn(s) 1 1
Hypoxia 1 1
Eye Injury 1 1
Muscular Rigidity 1 1
Myocardial Infarction 1 1
Abdominal Pain 1 1
Bacterial Infection 1 1
Paraplegia 1 1
Chest Tightness/Pressure 1 1
Cardiac Perforation 1 1
Shock 1 1
Tingling 1 1
Unspecified Nervous System Problem 1 1
Implant Pain 1 1
Diminished Pulse Pressure 1 1

Recalls
Manufacturer Recall Class Date Posted
1 DePuy Spine, Inc. II Apr-03-2018
2 Howmedica Osteonics Corp. II May-05-2020
3 Stryker Instruments Div. of Stryker Corporation II Mar-28-2018
4 Stryker Instruments Div. of Stryker Corporation II Aug-15-2016
5 Stryker Spine II Jul-20-2021
6 Zavation II Jun-01-2021
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