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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
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
GLOBUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
GS MEDICAL CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
GS MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HANCHANG CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HYPREVENTION SAS
  SUBSTANTIALLY EQUIVALENT 1
JOLINE GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC SOFAMOR DANEK USA, INC.
  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
2017 191 191
2018 144 144
2019 227 227
2020 212 212
2021 345 345

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 195 195
Leak/Splash 166 166
Chemical Problem 134 134
Migration or Expulsion of Device 127 127
Appropriate Term/Code Not Available 83 83
Migration 66 66
Improper Chemical Reaction 60 60
Break 60 60
Fluid Leak 51 51
Failure to Eject 32 32
Coagulation in Device or Device Ingredient 22 22
Device Operates Differently Than Expected 20 20
Inflation Problem 17 17
Material Integrity Problem 16 16
No Apparent Adverse Event 14 14
Packaging Problem 12 12
Fracture 12 12
Difficult to Remove 7 7
Use of Device Problem 7 7
Material Too Rigid or Stiff 6 6
Entrapment of Device 6 6
Burst Container or Vessel 5 5
Mechanical Problem 5 5
No Flow 5 5
Activation Failure 5 5
Device Difficult to Maintain 4 4
Activation, Positioning or SeparationProblem 4 4
Device Difficult to Setup or Prepare 4 4
Clumping in Device or Device Ingredient 4 4
Crack 4 4
Filling Problem 4 4
Deflation Problem 3 3
Component Missing 3 3
Tear, Rip or Hole in Device Packaging 3 3
Separation Failure 3 3
Pressure Problem 3 3
Product Quality Problem 2 2
Failure to Advance 2 2
Detachment of Device or Device Component 2 2
Patient-Device Incompatibility 2 2
Device-Device Incompatibility 2 2
Decrease in Pressure 2 2
Improper or Incorrect Procedure or Method 2 2
Material Rupture 2 2
Material Separation 2 2
Excess Flow or Over-Infusion 2 2
Detachment Of Device Component 2 2
Use of Incorrect Control Settings 1 1
Failure to Cycle 1 1
Backflow 1 1
Loss of or Failure to Bond 1 1
Difficult to Insert 1 1
Failure to Discharge 1 1
Material Discolored 1 1
Short Fill 1 1
Misassembled 1 1
Delivered as Unsterile Product 1 1
Fitting Problem 1 1
Device Damaged Prior to Use 1 1
Off-Label Use 1 1
Incomplete or Missing Packaging 1 1
Difficult to Open or Close 1 1
Extrusion 1 1
Ambient Temperature Problem 1 1
Biocompatibility 1 1
Defective Device 1 1
Contamination /Decontamination Problem 1 1
Component or Accessory Incompatibility 1 1
Delivery System Failure 1 1
Mechanics Altered 1 1
Temperature Problem 1 1
Output Problem 1 1
Insufficient Information 1 1
Device Handling Problem 1 1
Physical Resistance/Sticking 1 1
Inaccurate Information 1 1
Patient Device Interaction Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 282 282
No Clinical Signs, Symptoms or Conditions 229 229
No Consequences Or Impact To Patient 148 148
Extravasation 94 94
No Code Available 80 80
Pain 64 64
Bone Fracture(s) 48 48
Foreign Body In Patient 28 28
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 26 26
Injury 22 22
Nerve Damage 17 17
Hematoma 17 17
Failure of Implant 16 16
Death 15 15
Unspecified Tissue Injury 15 15
No Patient Involvement 15 15
Post Operative Wound Infection 14 14
Non-union Bone Fracture 13 13
Pulmonary Embolism 13 13
Cardiac Arrest 10 10
Unspecified Infection 9 9
Device Embedded In Tissue or Plaque 8 8
Inadequate Pain Relief 7 7
Spinal Cord Injury 7 7
Sudden Cardiac Death 6 6
Osteolysis 6 6
Neurological Deficit/Dysfunction 6 6
Paralysis 6 6
Weakness 6 6
Arrhythmia 6 6
Hypersensitivity/Allergic reaction 5 5
Stenosis 5 5
Perforation of Vessels 5 5
Not Applicable 5 5
No Information 4 4
Embolism/Embolus 4 4
Insufficient Information 4 4
Embolism 4 4
Anaphylactic Shock 4 4
Cerebrospinal Fluid Leakage 4 4
Dyspnea 4 4
Dysphagia/ Odynophagia 3 3
Chest Pain 3 3
Stroke/CVA 3 3
Low Blood Pressure/ Hypotension 3 3
Necrosis 3 3
Pleural Effusion 3 3
Pneumonia 3 3
Impaired Healing 3 3
Blood Loss 3 3
Neck Pain 3 3
Physical Asymmetry 3 3
Ischemia Stroke 2 2
Respiratory Failure 2 2
Decreased Sensitivity 2 2
Cardiac Perforation 2 2
Ambulation Difficulties 2 2
Reaction 2 2
Loss of Range of Motion 2 2
Neuropathy 2 2
Spinal Column Injury 2 2
Tissue Damage 2 2
Discomfort 2 2
Wound Dehiscence 2 2
Inflammation 2 2
Laceration(s) 2 2
Hemorrhage/Bleeding 2 2
Edema 2 2
Bacterial Infection 2 2
Burn(s) 1 1
Aspiration/Inhalation 1 1
Anemia 1 1
Abdominal Pain 1 1
Hepatitis 1 1
Eye Injury 1 1
Fall 1 1
Fatigue 1 1
Muscle Weakness 1 1
Muscular Rigidity 1 1
Myocardial Infarction 1 1
Hypoxia 1 1
Tingling 1 1
Internal Organ Perforation 1 1
Shock 1 1
Numbness 1 1
Collapse 1 1
Hypoesthesia 1 1
Deformity/ Disfigurement 1 1
Diminished Pulse Pressure 1 1
Paraplegia 1 1
Chest Tightness/Pressure 1 1
Fluid Discharge 1 1
Osteopenia/ Osteoporosis 1 1
Convulsion/Seizure 1 1
Paresthesia 1 1
Unspecified Nervous System Problem 1 1
Intervertebral Disc Compression or Protrusion 1 1
Swelling/ Edema 1 1
Implant Pain 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 Spine II Jul-20-2021
5 Zavation II Jun-01-2021
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