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13,363 catalysts · 3,603 8k filing · 2,401 grant · 2,054 approval · 1,400 device 510k · 1,000 device adverse event · 944 device recall
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13,363 catalysts · 3,603 8k filing · 2,401 grant · 2,054 approval · 1,400 device 510k · 1,000 device adverse event · 944 device recall
Incorrect Interpretation of Signal
Patient Device Interaction Problem
Calcified; Gradient Increase
Material Fragmentation
Failure to Seal
Adverse Event Without Identified Device or Use Problem
Pumping Stopped
Break; Material Rupture
Device Alarm System; Premature Discharge of Battery
Failure to Capture; High Capture Threshold
Adverse Event Without Identified Device or Use Problem
Gradient Increase; Thickening of Material
Malposition of Device; Patient Device Interaction Problem
Patient Device Interaction Problem
Patient Device Interaction Problem
Material Fragmentation
Adverse Event Without Identified Device or Use Problem
Migration
Insufficient Information
Impedance Problem
Device Dislodged or Dislocated
Naturally Worn
Failure to Osseointegrate
Osseointegration Problem
Structural Problem
Adverse Event Without Identified Device or Use Problem
Adverse Event Without Identified Device or Use Problem
Adverse Event Without Identified Device or Use Problem
Adverse Event Without Identified Device or Use Problem
Adverse Event Without Identified Device or Use Problem
Infusion or Flow Problem; Material Twisted/Bent
Infusion or Flow Problem; Material Twisted/Bent
Adverse Event Without Identified Device or Use Problem
Adverse Event Without Identified Device or Use Problem
Adverse Event Without Identified Device or Use Problem
Adverse Event Without Identified Device or Use Problem
Adverse Event Without Identified Device or Use Problem
Infusion or Flow Problem; Material Twisted/Bent
Patient Device Interaction Problem
Infusion or Flow Problem; Material Twisted/Bent
Infusion or Flow Problem; Material Twisted/Bent
Infusion or Flow Problem; Material Twisted/Bent
Infusion or Flow Problem; Material Twisted/Bent
Malposition of Device
Device Dislodged or Dislocated
Infusion or Flow Problem; Material Twisted/Bent
Infusion or Flow Problem; Material Twisted/Bent
Infusion or Flow Problem; Material Twisted/Bent
Infusion or Flow Problem; Material Twisted/Bent
Device Dislodged or Dislocated