DEVICE NAME:
PRODUCT CODE – DESCRIPTION
KWP – Appliance, Fixation, Spinal Interlaminal
KWQ – Appliance, Fixation, Spinal Intervertebral Boday
MNH – Orthosis, Spondylolisthesis Spinal Fixation
MNI – Orthosis, Spinal Pedicle Fixation
KNB – Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
OSH – Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
REPORTING PERIOD: JANUARY 2010 – MARCH 2020
ADVERSE EVENTS RECEIVED BY THE FDA FROM:
TOTAL……………………..34,500
INJURY……………………20,099
MALFUNCTION………….13,983
DEATH………………………..131
OTHER……………………….287
View Signals Newsletter – April 2020 – Spinal Stabilization and Fusion Systems