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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
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
XELITE BIOMED LTD.
  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 416 418

Device Problems MDRs with this Device Problem Events in those MDRs
Improper Chemical Reaction 260 260
Adverse Event Without Identified Device or Use Problem 245 245
Leak/Splash 187 187
Fluid/Blood Leak 171 171
Chemical Problem 160 160
Migration or Expulsion of Device 155 155
Failure to Eject 125 125
Material Integrity Problem 125 125
Inflation Problem 107 107
Migration 89 89
Coagulation in Device or Device Ingredient 70 70
Break 64 64
Compatibility Problem 30 30
Appropriate Term/Code Not Available 24 24
Fracture 20 22
No Apparent Adverse Event 19 19
Insufficient Information 17 17
Entrapment of Device 16 16
Activation Failure 13 14
Product Quality Problem 12 12
Packaging Problem 12 12
Activation, Positioning or Separation Problem 11 11
Difficult or Delayed Separation 11 15
Separation Failure 10 10
Improper or Incorrect Procedure or Method 7 7
Device-Device Incompatibility 6 6
Mechanical Problem 6 6
Crack 6 6
Difficult to Remove 5 5
Patient Device Interaction Problem 5 5
Device Handling Problem 5 5
Device Damaged Prior to Use 4 4
Clumping in Device or Device Ingredient 4 4
Device Difficult to Setup or Prepare 4 4
Use of Device Problem 4 4
Device Difficult to Maintain 4 4
Detachment of Device or Device Component 3 3
Tear, Rip or Hole in Device Packaging 3 3
Material Separation 3 3
Excess Flow or Over-Infusion 3 3
Deflation Problem 3 3
Expiration Date Error 3 3
Pressure Problem 3 3
Device Ingredient or Reagent Problem 3 3
Mechanics Altered 2 2
Material Rupture 2 2
Material Fragmentation 2 2
Contamination /Decontamination Problem 2 2
Inaccurate Information 2 2
Problem with Sterilization 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 941 948
Insufficient Information 150 151
Extravasation 139 139
No Known Impact Or Consequence To Patient 110 110
No Consequences Or Impact To Patient 104 104
Pain 64 64
Bone Fracture(s) 64 64
No Code Available 52 52
Nerve Damage 40 40
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 37 37
Foreign Body In Patient 37 37
Pulmonary Embolism 28 28
Unspecified Tissue Injury 28 28
Post Operative Wound Infection 26 26
Osteolysis 26 26
Unspecified Infection 26 26
Hematoma 25 25
Failure of Implant 24 24
Non-union Bone Fracture 24 24
Joint Laxity 21 21
Injury 16 16
Embolism/Embolus 15 15
Decreased Sensitivity 13 13
Cerebrospinal Fluid Leakage 12 12
Spinal Cord Injury 10 10
Necrosis 10 10
Cardiac Arrest 10 10
Dyspnea 10 10
Vertebral Fracture 9 9
Perforation of Vessels 9 9
No Patient Involvement 9 9
Death 8 8
Arrhythmia 8 8
Device Embedded In Tissue or Plaque 7 7
Impaired Healing 7 7
Paralysis 7 7
Chest Pain 6 6
Stenosis 6 6
Weakness 6 6
Unspecified Nervous System Problem 6 6
Physical Asymmetry 5 5
Hypersensitivity/Allergic reaction 5 5
Inflammation 5 5
Neck Pain 5 5
Pleural Effusion 4 4
Thrombosis/Thrombus 4 4
Loss of Range of Motion 4 4
Neurological Deficit/Dysfunction 4 4
Pneumonia 4 4
Dysphagia/ Odynophagia 4 4

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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