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 needle, spinal, short term
Product CodeMIA
Regulation Number 868.5150
Device Class 2


Premarket Reviews
ManufacturerDecision
SMITHS MEDICAL ASD, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 4 4
2015 12 12
2016 23 23
2017 15 15
2018 14 14
2019 9 9
2020 5 5
2021 4 4
2022 19 19
2023 12 12
2024 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Break 52 52
Protective Measures Problem 14 14
Material Fragmentation 10 10
Product Quality Problem 10 10
Device Issue 8 8
Defective Component 7 7
Defective Device 6 6
Manufacturing, Packaging or Shipping Problem 6 6
Fluid/Blood Leak 6 6
Detachment of Device or Device Component 4 4
Fracture 3 3
Device Damaged Prior to Use 3 3
Entrapment of Device 3 3
Contamination 3 3
Difficult to Remove 3 3
Retraction Problem 2 2
Material Separation 2 2
Leak/Splash 2 2
Crack 2 2
Detachment Of Device Component 2 2
Malposition of Device 2 2
Device Markings/Labelling Problem 2 2
Device Damaged by Another Device 2 2
Material Twisted/Bent 2 2
Device Contamination with Chemical or Other Material 2 2
Positioning Problem 2 2
Device Handling Problem 2 2
Illegible Information 1 1
Wrong Label 1 1
Therapeutic or Diagnostic Output Failure 1 1
Mechanical Jam 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Material Deformation 1 1
Material Integrity Problem 1 1
Device Packaging Compromised 1 1
Device Dislodged or Dislocated 1 1
Structural Problem 1 1
Failure to Deliver 1 1
Bent 1 1
Flushing Problem 1 1
Device Difficult to Setup or Prepare 1 1
Hole In Material 1 1
Kinked 1 1
Device Slipped 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Device Embedded In Tissue or Plaque 35 35
No Clinical Signs, Symptoms or Conditions 23 23
Foreign Body In Patient 18 18
No Information 17 17
No Known Impact Or Consequence To Patient 15 15
Numbness 5 5
Pain 4 4
No Consequences Or Impact To Patient 3 3
Insufficient Information 3 3
Laceration(s) 2 2
Needle Stick/Puncture 2 2
Missed Dose 1 1
Neck Stiffness 1 1
Pregnancy 1 1
Paresthesia 1 1
Muscle Spasm(s) 1 1
Muscle Weakness 1 1
Vessel Or Plaque, Device Embedded In 1 1
Bone Fracture(s) 1 1
Distress 1 1
Injury 1 1
Burning Sensation 1 1

-
-