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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device shunt, central nervous system and components
Product CodeJXG
Regulation Number 882.5550
Device Class 2


Premarket Reviews
ManufacturerDecision
AESCULAP INC.
  SUBSTANTIALLY EQUIVALENT 1
AESCULAP, INC.
  SUBSTANTIALLY EQUIVALENT 3
ALCYONE LIFESCIENCES. INC.
  SUBSTANTIALLY EQUIVALENT 1
ANUNCIA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
AQUEDUCT CRITICAL CARE, INC
  SUBSTANTIALLY EQUIVALENT 1
AQUEDUCT CRITICAL CARE, INC.
  SUBSTANTIALLY EQUIVALENT 2
ARKIS BIOSCIENCES INC.
  SUBSTANTIALLY EQUIVALENT 1
BTG INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 2
INTEGRA LIFESCIENCES CORP.
  SUBSTANTIALLY EQUIVALENT 2
INTEGRA LIFESCIENCES CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
IRRAS INC.
  SUBSTANTIALLY EQUIVALENT 1
IRRAS USA INC.
  SUBSTANTIALLY EQUIVALENT 1
IRRAS USA, LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC NEUROSURGERY
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2017 1333 1333
2018 1482 1482
2019 1295 1295
2020 1206 1206
2021 1467 1467
2022 1125 1128

Device Problems MDRs with this Device Problem Events in those MDRs
Infusion or Flow Problem 1614 1614
Mechanical Problem 757 757
Adverse Event Without Identified Device or Use Problem 707 707
Insufficient Information 658 658
Obstruction of Flow 653 653
Break 555 555
Appropriate Term/Code Not Available 497 497
Device Operates Differently Than Expected 411 411
Fluid/Blood Leak 296 296
Fracture 186 186
Leak/Splash 153 153
Mechanics Altered 151 151
Programming Issue 148 148
Occlusion Within Device 147 147
Complete Blockage 141 141
Pressure Problem 108 108
Device Difficult to Program or Calibrate 102 102
Disconnection 96 96
Device Dislodged or Dislocated 94 94
Output Problem 92 92
Partial Blockage 85 85
Device Operational Issue 83 83
Crack 81 81
Mechanical Jam 79 79
No Flow 73 73
Electrical /Electronic Property Problem 65 65
Migration 63 63
Inaccurate Flow Rate 61 61
Excess Flow or Over-Infusion 60 60
Migration or Expulsion of Device 56 56
Material Separation 51 51
Insufficient Flow or Under Infusion 50 50
Material Integrity Problem 48 48
Detachment of Device or Device Component 43 43
Defective Device 42 42
Improper Flow or Infusion 38 38
Material Split, Cut or Torn 33 33
Blocked Connection 28 28
Use of Device Problem 26 26
Material Fragmentation 26 26
Separation Problem 24 24
Defective Component 23 23
Activation, Positioning or Separation Problem 22 22
Device Misassembled During Manufacturing /Shipping 22 22
Incorrect, Inadequate or Imprecise Result or Readings 20 20
Overheating of Device 20 20
Loose or Intermittent Connection 17 17
Detachment Of Device Component 17 17
Material Twisted/Bent 14 14
Overcorrection 14 14
Positioning Problem 13 13
No Device Output 13 13
Material Puncture/Hole 13 13
Increase in Pressure 11 11
Device Appears to Trigger Rejection 10 10
Patient-Device Incompatibility 10 10
Manufacturing, Packaging or Shipping Problem 10 10
Therapeutic or Diagnostic Output Failure 9 9
Physical Resistance/Sticking 9 9
Material Rupture 9 9
Restricted Flow rate 9 9
Product Quality Problem 8 8
Retraction Problem 8 8
Difficult to Remove 8 8
Component Missing 8 8
Failure to Advance 8 8
Device Markings/Labelling Problem 8 8
Connection Problem 8 8
Unintended Movement 8 8
Free or Unrestricted Flow 8 8
Torn Material 7 7
Reset Problem 7 7
Excessive Heating 7 7
Malposition of Device 7 7
Improper or Incorrect Procedure or Method 7 7
Misassembled 7 7
Nonstandard Device 7 7
Kinked 7 7
Material Frayed 7 7
Entrapment of Device 6 6
Incorrect Measurement 6 6
Failure to Auto Stop 6 6
Device Or Device Fragments Location Unknown 6 6
Inappropriate or Unexpected Reset 6 6
Material Deformation 6 6
Material Protrusion/Extrusion 5 5
No Apparent Adverse Event 5 5
Device Fell 5 5
Separation Failure 5 5
Device Inoperable 5 5
Hole In Material 5 5
Material Discolored 5 5
Calcified 5 5
Flushing Problem 4 4
Unable to Obtain Readings 4 4
Failure to Prime 4 4
Decrease in Pressure 4 4
Device Slipped 4 4
Self-Activation or Keying 4 4
Device Damaged Prior to Use 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hydrocephalus 1562 1562
No Known Impact Or Consequence To Patient 1391 1391
Failure of Implant 653 653
No Clinical Signs, Symptoms or Conditions 615 615
No Information 611 611
Injury 531 531
Unspecified Infection 434 434
Headache 434 435
Therapeutic Response, Decreased 309 309
Cerebrospinal Fluid Leakage 196 196
Patient Problem/Medical Problem 178 178
No Consequences Or Impact To Patient 168 168
Therapeutic Effects, Unexpected 162 162
Vomiting 153 153
Insufficient Information 145 145
Cerebral Ventriculomeglia 121 121
Ambulation Difficulties 115 115
No Code Available 95 95
Hematoma 89 89
Pain 81 82
Nausea 76 77
Dizziness 70 70
Cognitive Changes 69 69
Neurological Deficit/Dysfunction 64 64
Complaint, Ill-Defined 60 60
Fever 59 59
Bacterial Infection 54 54
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 49 49
Coma 48 48
Device Embedded In Tissue or Plaque 47 47
Death 45 45
Intracranial Hemorrhage 45 45
Visual Impairment 45 45
Fatigue 42 43
Confusion/ Disorientation 40 40
Unspecified Tissue Injury 38 38
Lethargy 37 37
Foreign Body In Patient 34 34
Swelling 34 35
Seizures 34 34
Hemorrhage/Bleeding 33 33
Loss of consciousness 31 31
Convulsion/Seizure 28 28
Hemorrhage, Subdural 27 27
Discomfort 25 26
Blurred Vision 24 24
Meningitis 24 24
Seroma 24 24
Dysphasia 22 22
Malaise 20 20
Incontinence 20 20
Cyst(s) 20 20
Swelling/ Edema 20 20
Erosion 19 19
Staphylococcus Aureus 19 19
Abdominal Pain 18 18
Hypersensitivity/Allergic reaction 18 18
Inflammation 18 18
Brain Injury 17 17
Irritability 16 16
Impaired Healing 14 14
Memory Loss/Impairment 14 14
Muscle Weakness 14 14
Wound Dehiscence 14 14
Hemorrhage, Cerebral 13 13
No Patient Involvement 13 13
Loss of Vision 12 12
Vertigo 11 11
Visual Disturbances 10 10
Weakness 10 10
Tissue Damage 10 10
Hearing Impairment 10 10
Edema 10 10
Dysphagia/ Odynophagia 10 10
Emotional Changes 9 9
Hemorrhage, Intraventricular 9 9
Urinary Tract Infection 9 9
Paralysis 9 9
Paresis 9 9
Sleep Dysfunction 9 9
Post Operative Wound Infection 9 9
Fluid Discharge 9 9
Neck Stiffness 8 8
Pneumonia 8 8
Tinnitus 8 8
Sepsis 8 8
Fall 8 8
Muscular Rigidity 8 8
Erythema 8 8
Abscess 8 8
Adhesion(s) 8 8
Stroke/CVA 8 8
Arrhythmia 7 7
Laceration(s) 7 7
High Blood Pressure/ Hypertension 7 7
Fungal Infection 7 7
Obstruction/Occlusion 7 7
Respiratory Failure 7 7
Bowel Perforation 7 7
Tissue Breakdown 7 7

Recalls
Manufacturer Recall Class Date Posted
1 Aesculap Implant Systems LLC II Mar-01-2018
2 Integra LifeSciences Corp. II Dec-23-2020
3 Integra LifeSciences Corp. I May-20-2019
4 Medtronic Neurosurgery II Feb-12-2021
5 Medtronic Neurosurgery II Jan-15-2021
6 Medtronic Neurosurgery II Dec-28-2020
7 Medtronic Neurosurgery I Apr-07-2017
8 Medtronic Neurosurgery II Feb-02-2017
9 Natus Manufacturing Limited II Feb-22-2021
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