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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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
2017 15 15
2018 14 14
2019 9 9
2020 5 5
2021 4 4
2022 18 18

Device Problems MDRs with this Device Problem Events in those MDRs
Break 26 26
Material Fragmentation 8 8
Product Quality Problem 4 4
Fluid Leak 4 4
Contamination 3 3
Device Damaged Prior to Use 3 3
Defective Component 3 3
Detachment of Device or Device Component 3 3
Device Markings/Labelling Problem 2 2
Device Contamination with Chemical or Other Material 2 2
Material Deformation 1 1
Material Twisted/Bent 1 1
Positioning Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Device Dislodged or Dislocated 1 1
Malposition of Device 1 1
Crack 1 1
Entrapment of Device 1 1
Detachment Of Device Component 1 1
Device Slipped 1 1
Leak/Splash 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Device Embedded In Tissue or Plaque 20 20
No Clinical Signs, Symptoms or Conditions 17 17
No Known Impact Or Consequence To Patient 7 7
Foreign Body In Patient 5 5
No Information 4 4
Numbness 4 4
No Consequences Or Impact To Patient 3 3
Pain 3 3
Laceration(s) 2 2
Muscle Spasm(s) 1 1
Muscle Weakness 1 1
Burning Sensation 1 1
Distress 1 1
Missed Dose 1 1
Pregnancy 1 1
Vessel Or Plaque, Device Embedded In 1 1

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