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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

MDR Year MDR Reports MDR Events
2019 9 9
2020 5 5
2021 4 4
2022 19 19
2023 12 12
2024 15 15

Device Problems MDRs with this Device Problem Events in those MDRs
Break 22 22
Material Fragmentation 4 4
Product Quality Problem 4 4
Detachment of Device or Device Component 4 4
Device Damaged Prior to Use 3 3
Contamination 3 3
Fracture 3 3
Crack 2 2
Device Markings/Labelling Problem 2 2
Material Twisted/Bent 2 2
Fluid/Blood Leak 2 2
Leak/Splash 1 1
Malposition of Device 1 1
Wrong Label 1 1
Defective Component 1 1
Material Integrity Problem 1 1
Positioning Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Failure to Deliver 1 1
Device Difficult to Setup or Prepare 1 1
Material Deformation 1 1
Material Separation 1 1
Device Contamination with Chemical or Other Material 1 1
Illegible Information 1 1
Device Dislodged or Dislocated 1 1
Mechanical Jam 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 24 24
Foreign Body In Patient 18 18
Device Embedded In Tissue or Plaque 5 5
Numbness 4 4
No Known Impact Or Consequence To Patient 3 3
Insufficient Information 3 3
No Information 2 2
Pain 2 2
Vessel Or Plaque, Device Embedded In 1 1
Muscle Weakness 1 1
Paresthesia 1 1
Burning Sensation 1 1
Needle Stick/Puncture 1 1
Muscle Spasm(s) 1 1
No Consequences Or Impact To Patient 1 1
Distress 1 1

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