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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
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
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 56 56

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 223 223
Improper Chemical Reaction 184 184
Leak/Splash 168 168
Chemical Problem 150 150
Migration or Expulsion of Device 136 136
Fluid/Blood Leak 128 128
Material Integrity Problem 82 82
Migration 78 78
Failure to Eject 77 77
Inflation Problem 57 57
Break 52 52
Coagulation in Device or Device Ingredient 25 25
Appropriate Term/Code Not Available 23 23
No Apparent Adverse Event 18 18
Fracture 17 19
Entrapment of Device 12 12
Packaging Problem 12 12
Compatibility Problem 11 11
Insufficient Information 10 10
Activation Failure 9 10
Activation, Positioning or Separation Problem 9 9
Separation Failure 9 9
Difficult or Delayed Separation 8 10
Device Handling Problem 5 5
Device-Device Incompatibility 5 5
Difficult to Remove 5 5
Crack 5 5
Clumping in Device or Device Ingredient 4 4
Mechanical Problem 4 4
Improper or Incorrect Procedure or Method 4 4
Device Difficult to Maintain 4 4
Patient Device Interaction Problem 3 3
Use of Device Problem 3 3
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
Detachment of Device or Device Component 2 2
Inaccurate Information 2 2
Device Ingredient or Reagent Problem 1 1
Contamination /Decontamination Problem 1 1
Component or Accessory Incompatibility 1 1
Difficult to Open or Close 1 1
Device Dislodged or Dislocated 1 1
Positioning Problem 1 1
Mechanical Jam 1 1
Mechanics Altered 1 1
Osseointegration Problem 1 1
Output Problem 1 1
Short Fill 1 1
Problem with Sterilization 1 1
Off-Label Use 1 1
Misassembled 1 1
Nonstandard Device 1 1
Patient-Device Incompatibility 1 1
Biocompatibility 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 679 684
Extravasation 132 132
No Known Impact Or Consequence To Patient 110 110
No Consequences Or Impact To Patient 104 104
Insufficient Information 66 67
Pain 58 58
Bone Fracture(s) 56 56
No Code Available 52 52
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 36 36
Nerve Damage 36 36
Foreign Body In Patient 28 28
Unspecified Tissue Injury 26 26
Pulmonary Embolism 23 23
Non-union Bone Fracture 22 22
Post Operative Wound Infection 22 22
Hematoma 21 21
Osteolysis 20 20
Failure of Implant 20 20
Injury 16 16
Unspecified Infection 16 16
Joint Laxity 15 15
Embolism/Embolus 14 14
Decreased Sensitivity 10 10
No Patient Involvement 9 9
Spinal Cord Injury 9 9
Vertebral Fracture 9 9
Cardiac Arrest 9 9
Dyspnea 9 9
Death 8 8
Cerebrospinal Fluid Leakage 8 8
Perforation of Vessels 8 8
Paralysis 7 7
Arrhythmia 7 7
Chest Pain 6 6
Necrosis 6 6
Weakness 6 6
Stenosis 6 6
Device Embedded In Tissue or Plaque 6 6
Neck Pain 5 5
Physical Asymmetry 5 5
Impaired Healing 5 5
Hypersensitivity/Allergic reaction 5 5
Neurological Deficit/Dysfunction 4 4
Pneumonia 4 4
Swelling/ Edema 4 4
Ambulation Difficulties 4 4
Pleural Effusion 3 3
Unspecified Nervous System Problem 3 3
Cancer 3 3
Loss of Range of Motion 3 3
Muscle Weakness 3 3
Numbness 3 3
Low Blood Pressure/ Hypotension 3 3
Inflammation 3 3
Dysphagia/ Odynophagia 3 3
Edema 2 2
Stroke/CVA 2 2
Wound Dehiscence 2 2
Bacterial Infection 2 2
Adult Respiratory Distress Syndrome 2 2
Hypoxia 2 2
Fever 2 2
Hemorrhage/Bleeding 2 2
Myocardial Infarction 2 2
Spinal Column Injury 2 2
Tissue Damage 2 2
Foreign Body Embolism 2 2
Thrombosis/Thrombus 2 2
Implant Pain 2 2
Ischemia Stroke 2 2
Not Applicable 2 2
Blood Loss 2 2
Sudden Cardiac Death 2 2
Paraplegia 2 2
Respiratory Failure 1 1
Cardiac Perforation 1 1
Sleep Dysfunction 1 1
Pseudoaneurysm 1 1
Osteopenia/ Osteoporosis 1 1
Fluid Discharge 1 1
Paresthesia 1 1
Intervertebral Disc Compression or Protrusion 1 1
Tricuspid Valve Insufficiency/ Regurgitation 1 1
Convulsion/Seizure 1 1
Peripheral Nervous Injury 1 1
Paresis 1 1
Rash 1 1
Renal Failure 1 1
Sepsis 1 1
Shock 1 1
Internal Organ Perforation 1 1
Muscular Rigidity 1 1
Incontinence 1 1
Collapse 1 1
Hypoesthesia 1 1
Deformity/ Disfigurement 1 1
Depression 1 1
Anxiety 1 1
Discomfort 1 1
Tingling 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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