Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 7
ALCYONE LIFESCIENCES. INC.
  SUBSTANTIALLY EQUIVALENT 1
ANUNCIA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
AQUEDUCT CRITICAL CARE, INC
  SUBSTANTIALLY EQUIVALENT 1
AQUEDUCT CRITICAL CARE, INC.
  SUBSTANTIALLY EQUIVALENT 3
ARKIS BIOSCIENCES INC.
  SUBSTANTIALLY EQUIVALENT 1
BTG INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 9
INTEGRA LIFESCIENCES CORP.
  SUBSTANTIALLY EQUIVALENT 3
INTEGRA LIFESCIENCES CORPORATION
  SUBSTANTIALLY EQUIVALENT 7
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
IRRAS INC.
  SUBSTANTIALLY EQUIVALENT 1
IRRAS USA
  SUBSTANTIALLY EQUIVALENT 1
IRRAS USA INC.
  SUBSTANTIALLY EQUIVALENT 2
IRRAS USA, LTD.
  SUBSTANTIALLY EQUIVALENT 1
JMED(SHENZHEN) TECHNOLOGY LIMITED
  SUBSTANTIALLY EQUIVALENT 1
MEDOS INTERNATIONAL SARL
  SUBSTANTIALLY EQUIVALENT 4
MEDTRONIC NEUROSURGERY
  SUBSTANTIALLY EQUIVALENT 6
MOLLER MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 2
NEURODX DEVELOPMENT LLC
  SUBSTANTIALLY EQUIVALENT 1
SOPHYSA
  SUBSTANTIALLY EQUIVALENT 1
SOPHYSA SA
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2014 1251 1251
2015 984 984
2016 1090 1090
2017 1333 1333
2018 1484 1484
2019 1295 1295
2020 1206 1206
2021 1467 1467
2022 1329 1330
2023 1221 1221
2024 264 264

Device Problems MDRs with this Device Problem Events in those MDRs
Infusion or Flow Problem 2244 2244
Mechanical Problem 1058 1058
Adverse Event Without Identified Device or Use Problem 1045 1045
Break 980 980
Insufficient Information 936 936
Obstruction of Flow 845 845
Appropriate Term/Code Not Available 824 824
Occlusion Within Device 516 516
Leak/Splash 498 498
Device Operates Differently Than Expected 496 496
Fluid/Blood Leak 423 423
Programming Issue 384 384
Pressure Problem 292 292
No Flow 273 273
Fracture 268 268
Disconnection 258 258
Complete Blockage 220 220
Partial Blockage 183 183
Mechanics Altered 182 182
Crack 172 172
Device Dislodged or Dislocated 165 165
Device Difficult to Program or Calibrate 143 143
Excess Flow or Over-Infusion 137 137
Insufficient Flow or Under Infusion 135 135
Mechanical Jam 126 126
Improper Flow or Infusion 121 121
Use of Device Problem 112 112
Output Problem 107 107
Device Operational Issue 97 97
Inaccurate Flow Rate 87 87
Migration or Expulsion of Device 81 81
Migration 78 78
Material Separation 70 70
Electrical /Electronic Property Problem 65 65
Detachment of Device or Device Component 63 63
Material Integrity Problem 59 59
Defective Device 56 56
Detachment Of Device Component 51 51
Material Split, Cut or Torn 49 49
Device Issue 42 42
Material Fragmentation 37 37
Defective Component 34 34
Material Puncture/Hole 31 31
Incorrect, Inadequate or Imprecise Result or Readings 30 30
Loose or Intermittent Connection 30 30
Separation Problem 29 29
Blocked Connection 29 29
Positioning Problem 28 28
Cut In Material 27 27
Connection Problem 24 24
Device Misassembled During Manufacturing /Shipping 24 24
Activation, Positioning or Separation Problem 23 23
Torn Material 23 23
Overheating of Device 23 23
Difficult to Remove 22 22
Device Inoperable 22 22
Hole In Material 20 20
No Device Output 19 19
Material Twisted/Bent 19 19
Improper or Incorrect Procedure or Method 17 17
Component Missing 16 16
Sticking 16 16
Product Quality Problem 16 16
Device Contamination with Chemical or Other Material 15 15
Overcorrection 14 14
Unintended Movement 14 14
Failure to Prime 13 13
Kinked 13 13
Nonstandard Device 12 12
Restricted Flow rate 12 12
Increase in Pressure 12 12
Material Rupture 12 12
Microbial Contamination of Device 12 12
Therapeutic or Diagnostic Output Failure 12 12
Device Markings/Labelling Problem 12 12
Malposition of Device 12 12
Manufacturing, Packaging or Shipping Problem 11 11
Physical Resistance/Sticking 11 11
Failure to Advance 11 11
Retraction Problem 11 11
Flushing Problem 11 11
Air Leak 11 11
Use of Incorrect Control/Treatment Settings 10 10
Decrease in Pressure 10 10
Device Appears to Trigger Rejection 10 10
Packaging Problem 10 10
Patient-Device Incompatibility 10 10
Free or Unrestricted Flow 10 10
Operating System Becomes Nonfunctional 9 9
Excessive Heating 9 9
Reflux within Device 9 9
Material Frayed 9 9
Material Discolored 8 8
Component Falling 8 8
Device Slipped 8 8
Self-Activation or Keying 8 8
Unable to Obtain Readings 8 8
Split 8 8
Reset Problem 8 8
Material Deformation 8 8

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hydrocephalus 2229 2229
No Known Impact Or Consequence To Patient 2137 2137
No Information 1528 1528
No Clinical Signs, Symptoms or Conditions 960 960
Headache 672 673
Failure of Implant 663 663
Therapeutic Response, Decreased 659 659
Unspecified Infection 651 651
No Code Available 567 567
Injury 540 540
Insufficient Information 425 425
No Consequences Or Impact To Patient 336 336
Cerebrospinal Fluid Leakage 296 296
Vomiting 234 234
Patient Problem/Medical Problem 178 178
Cerebral Ventriculomeglia 173 173
Therapeutic Effects, Unexpected 163 163
Ambulation Difficulties 142 142
Hematoma 132 132
Unspecified Tissue Injury 125 125
Fever 113 113
Pain 112 113
Nausea 107 108
Dizziness 106 106
Death 88 88
Bacterial Infection 84 84
Coma 83 83
Device Embedded In Tissue or Plaque 81 81
Cognitive Changes 80 80
Complaint, Ill-Defined 79 79
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 76 76
Neurological Deficit/Dysfunction 69 69
Confusion/ Disorientation 66 66
Intracranial Hemorrhage 64 64
Foreign Body In Patient 59 59
Visual Impairment 58 58
Hemorrhage/Bleeding 54 54
Swelling 52 53
Lethargy 49 49
Meningitis 48 48
Fatigue 48 49
Loss of consciousness 46 46
Convulsion/Seizure 44 44
Seizures 42 42
No Patient Involvement 36 36
Discomfort 35 36
Swelling/ Edema 30 30
Hemorrhage, Subdural 29 29
Blurred Vision 28 28
Abdominal Pain 27 27
Inflammation 26 26
Dysphasia 26 26
Brain Injury 26 26
Seroma 26 26
Cyst(s) 24 24
High Blood Pressure/ Hypertension 23 23
Incontinence 23 23
Erosion 20 20
Malaise 20 20
Impaired Healing 19 19
Irritability 19 19
Hypersensitivity/Allergic reaction 19 19
Staphylococcus Aureus 19 19
Memory Loss/Impairment 18 18
Muscle Weakness 17 17
Wound Dehiscence 17 17
Edema 16 16
Loss of Vision 16 16
Visual Disturbances 14 14
Paralysis 14 14
Hemorrhage, Cerebral 14 14
Fall 14 14
Hemorrhage, Intraventricular 13 13
Abscess 13 13
Sleep Dysfunction 13 13
Post Operative Wound Infection 13 13
Unspecified Nervous System Problem 13 13
Reaction 12 12
Hearing Impairment 12 12
Erythema 12 12
Dysphagia/ Odynophagia 11 11
Vertigo 11 11
Urinary Tract Infection 11 11
Tissue Damage 11 11
Weakness 10 10
Paresis 10 10
Laceration(s) 10 10
Sepsis 10 10
Pneumonia 10 10
Stroke/CVA 10 10
Adhesion(s) 10 10
Arrhythmia 10 10
Emotional Changes 10 10
Neck Pain 10 10
Respiratory Failure 10 10
Fluid Discharge 10 10
Obstruction/Occlusion 9 9
Tinnitus 9 9
Muscular Rigidity 8 8
Irritation 8 8

Recalls
Manufacturer Recall Class Date Posted
1 Integra Neuro Sciences II Sep-08-2009
2 Aesculap Implant Systems LLC II Mar-01-2018
3 Aesculap, Inc. II Jan-26-2015
4 Aesculap, Inc. III Dec-16-2014
5 Aesculap, Inc. II Dec-03-2014
6 Aesculap, Inc. II Jun-02-2014
7 Aesculap, Inc. II Feb-19-2014
8 Aesculap, Inc. II Feb-12-2013
9 Codman & Shurtleff, Inc. II Oct-20-2014
10 Codman & Shurtleff, Inc. II Aug-12-2014
11 Codman & Shurtleff, Inc. II Apr-17-2014
12 Codman & Shurtleff, Inc. II Jan-29-2014
13 Integra LifeSciences Corp II Jul-10-2012
14 Integra LifeSciences Corp. II Dec-23-2020
15 Integra LifeSciences Corp. I May-20-2019
16 Integra LifeSciences Corp. II Sep-30-2016
17 Integra LifeSciences Corp. II Jan-03-2014
18 Integra LifeSciences Corp. d.b.a. Integra Pain Management II Dec-20-2013
19 Integra Neurosciences PR, Inc. II Feb-16-2012
20 Medtronic Neurosurgery II Aug-17-2023
21 Medtronic Neurosurgery II Feb-12-2021
22 Medtronic Neurosurgery II Jan-15-2021
23 Medtronic Neurosurgery II Dec-28-2020
24 Medtronic Neurosurgery I Apr-07-2017
25 Medtronic Neurosurgery II Feb-02-2017
26 Medtronic Neurosurgery I Jun-27-2014
27 Medtronic Neurosurgery II Nov-26-2013
28 Medtronic Neurosurgery I Mar-27-2009
29 Natus Manufacturing Limited II Feb-22-2021
30 Natus Medical Incorporated II Jan-04-2024
-
-