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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device device, monitoring, intracranial pressure
Product CodeGWM
Regulation Number 882.1620
Device Class 2


Premarket Reviews
ManufacturerDecision
BRAINCARE DESENVOLVIMENTO E INOVACAO TECNOLOGICA S.A.
  SUBSTANTIALLY EQUIVALENT 2
BRAINCARE DESENVOLVIMENTO E INOVAÇÃO TECNOLÓGICA S.A.
  SUBSTANTIALLY EQUIVALENT 1
BRANCHPOINT TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
CMA MICRODIALYSIS AB
  SUBSTANTIALLY EQUIVALENT 1
CODMAN & SHURTLEFF, INC
  SUBSTANTIALLY EQUIVALENT 1
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 1
DPCOM AS
  SUBSTANTIALLY EQUIVALENT 1
HEMEDEX INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
INNERSPACE NEURO SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
INNERSPACE, INC
  SUBSTANTIALLY EQUIVALENT 1
INNERSPACE, INC.
  SUBSTANTIALLY EQUIVALENT 1
INTEGRA LIFESCIENCE CORPORTATION
  SUBSTANTIALLY EQUIVALENT 1
INTEGRA LIFESCIENCES CORP.
  SUBSTANTIALLY EQUIVALENT 2
INTEGRA LIFESCIENCES CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
INTRGRA LIFESCIENCES CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MEDOS INTERNATIONAL SARL
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 3
RAUMEDIC AG
  SUBSTANTIALLY EQUIVALENT 5
SOPHYSA, SA
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 360 360
2015 486 486
2016 419 419
2017 439 439
2018 299 299
2019 260 260
2020 268 268
2021 211 211
2022 424 424
2023 746 746
2024 475 475

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 775 775
Break 494 494
Incorrect, Inadequate or Imprecise Result or Readings 466 466
Disconnection 391 391
Device Operates Differently Than Expected 254 254
Fracture 252 252
Device Displays Incorrect Message 192 192
Output Problem 168 168
Appropriate Term/Code Not Available 120 120
Leak/Splash 111 111
Unable to Obtain Readings 107 107
Low Readings 107 107
Incorrect Measurement 106 106
High Readings 99 99
Adverse Event Without Identified Device or Use Problem 91 91
Electrical /Electronic Property Problem 88 88
Use of Device Problem 78 78
Connection Problem 77 77
Device Operational Issue 70 70
Failure to Zero 70 70
Insufficient Information 70 70
Display or Visual Feedback Problem 66 66
Loose or Intermittent Connection 59 59
False Reading From Device Non-Compliance 57 57
Device Sensing Problem 56 56
Infusion or Flow Problem 54 54
No Display/Image 52 52
No Device Output 49 49
Device Inoperable 43 43
Device Dislodged or Dislocated 41 41
Failure to Read Input Signal 39 39
Defective Device 35 35
Complete Blockage 32 32
Improper Device Output 29 29
Signal Artifact/Noise 28 28
Failure to Power Up 28 28
Crack 27 27
Pressure Problem 27 27
Communication or Transmission Problem 26 26
Bent 23 23
Failure to Sense 22 22
Image Display Error/Artifact 20 20
Device Handling Problem 19 19
Defective Component 17 17
Occlusion Within Device 17 17
Difficult to Insert 17 17
Detachment Of Device Component 17 17
Battery Problem 17 17
Mechanical Problem 17 17
Mechanical Jam 16 16

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1482 1482
No Known Impact Or Consequence To Patient 1219 1219
No Information 499 499
No Consequences Or Impact To Patient 447 447
Insufficient Information 181 181
No Patient Involvement 172 172
No Code Available 119 119
Cerebrospinal Fluid Leakage 79 79
Failure of Implant 75 75
Injury 71 71
Unspecified Infection 57 57
Death 43 43
Device Embedded In Tissue or Plaque 30 30
Hematoma 23 23
Hemorrhage/Bleeding 21 21
Unspecified Tissue Injury 21 21
Complaint, Ill-Defined 18 18
Bacterial Infection 18 18
Foreign Body In Patient 15 15
Headache 15 15
Intracranial Hemorrhage 13 13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 12 12
Fever 12 12
Patient Problem/Medical Problem 10 10
Therapeutic Response, Decreased 10 10
Not Applicable 8 8
Neurological Deficit/Dysfunction 8 8
Brain Injury 6 6
Coma 6 6
Hydrocephalus 6 6
Vomiting 5 5
Hernia 4 4
Pain 4 4
Head Injury 4 4
Ambulation Difficulties 4 4
High Blood Pressure/ Hypertension 4 4
Edema 3 3
Malaise 3 3
Hemorrhage, Cerebral 3 3
Test Result 3 3
Hemorrhage, Subarachnoid 3 3
Therapeutic Effects, Unexpected 3 3
Meningitis 3 3
Swelling/ Edema 2 2
Aneurysm 2 2
Tissue Damage 2 2
Fall 2 2
Convulsion/Seizure 2 2
Pulmonary Embolism 2 2
Paralysis 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Codman & Shurtleff, Inc. II Mar-22-2012
2 Codman & Shurtleff, Inc. II Jan-11-2012
3 Codman & Shurtleff, Inc. II Apr-20-2011
4 Integra LifeSciences Corp III Feb-03-2012
5 Integra LifeSciences Corp. I Dec-14-2023
6 Integra LifeSciences Corp. II May-19-2023
7 Integra LifeSciences Corp. I Jul-22-2022
8 Integra LifeSciences Corp. II Oct-12-2019
9 Integra LifeSciences Corp. II Jun-18-2015
10 Integra LifeSciences Corp. II May-15-2015
11 Integra LifeSciences Corp. II Dec-18-2014
12 Integra LifeSciences Corp. II Nov-10-2014
13 Integra LifeSciences Corp. II May-30-2014
14 Integra LifeSciences Corp. II Dec-27-2013
15 Integra LifeSciences Corp. II Oct-23-2013
16 Integra LifeSciences Corp. II Mar-03-2011
17 Integra LifeSciences Corp. II Oct-28-2010
18 Integra LifeSciences Corp. II Apr-20-2010
19 Integra Limited II Oct-30-2013
20 Sophysa S.A. II May-15-2024
21 Spiegelberg Gmbh & Co. KG II Sep-26-2016
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