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13,309 catalysts · 3,603 8k filing · 2,401 grant · 2,049 approval · 1,383 device 510k · 1,000 device adverse event · 931 device pma
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13,309 catalysts · 3,603 8k filing · 2,401 grant · 2,049 approval · 1,383 device 510k · 1,000 device adverse event · 931 device pma
Patient-Device Incompatibility
Insufficient Information
Failure to Osseointegrate
Loss of Osseointegration
Electrical /Electronic Property Problem; Impedance Problem
Adverse Event Without Identified Device or Use Problem
Failure to Osseointegrate
Over-Sensing; Inappropriate/Inadequate Shock/Stimulation
Electrical /Electronic Property Problem; Under-Sensing
Material Rupture
Air/Gas in Device
Device Dislodged or Dislocated
Insufficient Information
Migration or Expulsion of Device
Use of Device Problem
Use of Incorrect Control/Treatment Settings
Use of Incorrect Control/Treatment Settings
Use of Incorrect Control/Treatment Settings
Use of Incorrect Control/Treatment Settings
Use of Incorrect Control/Treatment Settings
Adverse Event Without Identified Device or Use Problem
Adverse Event Without Identified Device or Use Problem
Use of Incorrect Control/Treatment Settings
Unintended Collision
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
Insufficient Information
Insufficient Information
Adverse Event Without Identified Device or Use Problem
Failure to Osseointegrate
Loss of Osseointegration
Fluid/Blood Leak; Device Dislodged or Dislocated
Adverse Event Without Identified Device or Use Problem
Malposition of Device
Pumping Stopped
Failure to Osseointegrate
Adverse Event Without Identified Device or Use Problem
Use of Device Problem
Adverse Event Without Identified Device or Use Problem
Device Dislodged or Dislocated
High impedance; Capturing Problem
Loss of Osseointegration
Adverse Event Without Identified Device or Use Problem
Adverse Event Without Identified Device or Use Problem
Insufficient Information
Premature Discharge of Battery
Device Dislodged or Dislocated
Adverse Event Without Identified Device or Use Problem