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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
Improper or Incorrect Procedure or Method
Loosening of Implant Not Related to Bone-Ingrowth
Patient Device Interaction Problem
Adverse Event Without Identified Device or Use Problem
Over-Sensing
Adverse Event Without Identified Device or Use Problem
Fluid/Blood Leak
Failure to Osseointegrate
Fluid/Blood Leak
Therapeutic or Diagnostic Output Failure
Adverse Event Without Identified Device or Use Problem
Adverse Event Without Identified Device or Use Problem
Adverse Event Without Identified Device or Use Problem
Failure to Osseointegrate
Adverse Event Without Identified Device or Use Problem
Pumping Stopped
Adverse Event Without Identified Device or Use Problem
Adverse Event Without Identified Device or Use Problem
Priming Problem
Adverse Event Without Identified Device or Use Problem
Patient Device Interaction Problem
Patient Device Interaction Problem
Failure to Osseointegrate
Osseointegration Problem
Fluid/Blood Leak
Adverse Event Without Identified Device or Use Problem
Failure to Osseointegrate
Improper or Incorrect Procedure or Method
Adverse Event Without Identified Device or Use Problem
Failure to Osseointegrate
Adverse Event Without Identified Device or Use Problem
Fracture
Fluid/Blood Leak
Fluid/Blood Leak
Insufficient Information
Insufficient Information
Adverse Event Without Identified Device or Use Problem
Signal Artifact/Noise
Incorrect Interpretation of Signal
Insufficient Information
Inappropriate/Inadequate Shock/Stimulation
Premature Discharge of Battery
Fluid/Blood Leak; Mechanical Problem
Adverse Event Without Identified Device or Use Problem
Charging Problem
Adverse Event Without Identified Device or Use Problem
Failure to Seal
Adverse Event Without Identified Device or Use Problem
Adverse Event Without Identified Device or Use Problem
Failure to Osseointegrate