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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 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
BORVO MEDICAL 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 753 753

Device Problems MDRs with this Device Problem Events in those MDRs
Infusion or Flow Problem 2426 2426
Mechanical Problem 1164 1164
Adverse Event Without Identified Device or Use Problem 1049 1049
Break 1012 1012
Insufficient Information 977 977
Obstruction of Flow 872 872
Appropriate Term/Code Not Available 826 826
Occlusion Within Device 516 516
Leak/Splash 514 514
Device Operates Differently Than Expected 496 496
Fluid/Blood Leak 459 459
Programming Issue 384 384
Pressure Problem 298 298
Fracture 280 280
No Flow 278 278
Disconnection 267 267
Complete Blockage 231 231
Mechanics Altered 197 197
Partial Blockage 184 184
Crack 177 177
Device Dislodged or Dislocated 167 167
Device Difficult to Program or Calibrate 150 150
Excess Flow or Over-Infusion 138 138
Insufficient Flow or Under Infusion 136 136
Mechanical Jam 134 134
Improper Flow or Infusion 121 121
Use of Device Problem 113 113
Output Problem 107 107
Device Operational Issue 97 97
Inaccurate Flow Rate 87 87
Migration 81 81
Migration or Expulsion of Device 81 81
Material Separation 73 73
Detachment of Device or Device Component 65 65
Electrical /Electronic Property Problem 65 65
Material Integrity Problem 60 60
Defective Device 56 56
Detachment Of Device Component 51 51
Material Split, Cut or Torn 51 51
Device Issue 42 42
Material Fragmentation 38 38
Defective Component 34 34
Loose or Intermittent Connection 33 33
Material Puncture/Hole 31 31
Incorrect, Inadequate or Imprecise Result or Readings 31 31
Blocked Connection 29 29
Separation Problem 29 29
Positioning Problem 28 28
Cut In Material 27 27
Connection Problem 25 25

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hydrocephalus 2438 2438
No Known Impact Or Consequence To Patient 2137 2137
No Information 1528 1528
No Clinical Signs, Symptoms or Conditions 1092 1092
Headache 688 689
Failure of Implant 666 666
Unspecified Infection 659 659
Therapeutic Response, Decreased 659 659
No Code Available 567 567
Injury 540 540
Insufficient Information 499 499
No Consequences Or Impact To Patient 336 336
Cerebrospinal Fluid Leakage 305 305
Vomiting 245 245
Cerebral Ventriculomeglia 178 178
Patient Problem/Medical Problem 178 178
Therapeutic Effects, Unexpected 163 163
Ambulation Difficulties 146 146
Hematoma 134 134
Unspecified Tissue Injury 129 129
Fever 116 116
Pain 115 116
Dizziness 113 113
Nausea 111 112
Bacterial Infection 89 89
Death 88 88
Device Embedded In Tissue or Plaque 83 83
Coma 83 83
Cognitive Changes 81 81
Complaint, Ill-Defined 79 79
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 77 77
Neurological Deficit/Dysfunction 69 69
Confusion/ Disorientation 68 68
Foreign Body In Patient 64 64
Intracranial Hemorrhage 64 64
Visual Impairment 59 59
Hemorrhage/Bleeding 57 57
Swelling 52 53
Meningitis 51 51
Fatigue 50 51
Loss of consciousness 50 50
Lethargy 49 49
Convulsion/Seizure 47 47
Seizures 42 42
Discomfort 38 39
No Patient Involvement 36 36
Swelling/ Edema 30 30
Hemorrhage, Subdural 29 29
Abdominal Pain 28 28
Inflammation 28 28

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 Jun-12-2024
15 Integra LifeSciences Corp. II Dec-23-2020
16 Integra LifeSciences Corp. I May-20-2019
17 Integra LifeSciences Corp. II Sep-30-2016
18 Integra LifeSciences Corp. II Jan-03-2014
19 Integra LifeSciences Corp. d.b.a. Integra Pain Management II Dec-20-2013
20 Integra Neurosciences PR, Inc. II Feb-16-2012
21 Medtronic Neurosurgery II Aug-17-2023
22 Medtronic Neurosurgery II Feb-12-2021
23 Medtronic Neurosurgery II Jan-15-2021
24 Medtronic Neurosurgery II Dec-28-2020
25 Medtronic Neurosurgery I Apr-07-2017
26 Medtronic Neurosurgery II Feb-02-2017
27 Medtronic Neurosurgery I Jun-27-2014
28 Medtronic Neurosurgery II Nov-26-2013
29 Medtronic Neurosurgery I Mar-27-2009
30 Natus Manufacturing Limited II Feb-22-2021
31 Natus Medical Incorporated II Jan-04-2024
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