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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
Detachment of Device or Device Component 4 4
Product Quality Problem 4 4
Device Damaged Prior to Use 3 3
Contamination 3 3
Fracture 3 3
Device Markings/Labelling Problem 2 2
Crack 2 2
Fluid/Blood Leak 2 2
Material Twisted/Bent 2 2
Leak/Splash 1 1
Wrong Label 1 1
Therapeutic or Diagnostic Output Failure 1 1
Material Integrity Problem 1 1
Positioning Problem 1 1
Defective Component 1 1
Failure to Deliver 1 1
Device Difficult to Setup or Prepare 1 1
Material Deformation 1 1
Malposition of Device 1 1
Device Contamination with Chemical or Other Material 1 1
Material Separation 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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