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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 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Break 19 19
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
Crack 2 2
Fluid/Blood Leak 2 2
Fracture 2 2
Device Markings/Labelling Problem 2 2
Material Twisted/Bent 2 2
Mechanical Jam 1 1
Positioning Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Illegible Information 1 1
Wrong Label 1 1
Device Dislodged or Dislocated 1 1
Device Contamination with Chemical or Other Material 1 1
Material Deformation 1 1
Material Integrity Problem 1 1
Defective Component 1 1
Failure to Deliver 1 1
Malposition of Device 1 1
Material Separation 1 1
Leak/Splash 1 1
Device Difficult to Setup or Prepare 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 23 23
Foreign Body In Patient 15 15
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
Burning Sensation 1 1
No Consequences Or Impact To Patient 1 1
Distress 1 1
Needle Stick/Puncture 1 1
Vessel Or Plaque, Device Embedded In 1 1
Muscle Spasm(s) 1 1
Muscle Weakness 1 1
Paresthesia 1 1

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