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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
2018 14 14
2019 9 9
2020 5 5
2021 4 4
2022 21 21
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 19 19
Material Fragmentation 6 6
Product Quality Problem 4 4
Device Damaged Prior to Use 3 3
Defective Component 3 3
Contamination 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 Twisted/Bent 2 2
Mechanical Jam 1 1
Positioning Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Material Deformation 1 1
Device Dislodged or Dislocated 1 1
Crack 1 1
Entrapment of Device 1 1
Fluid/Blood Leak 1 1
Failure to Deliver 1 1
Malposition of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 20 20
Device Embedded In Tissue or Plaque 15 15
Foreign Body In Patient 4 4
No Known Impact Or Consequence To Patient 4 4
Numbness 4 4
No Information 3 3
Pain 2 2
Burning Sensation 1 1
No Consequences Or Impact To Patient 1 1
Distress 1 1
Missed Dose 1 1
Vessel Or Plaque, Device Embedded In 1 1
Muscle Spasm(s) 1 1
Muscle Weakness 1 1

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