Signal Newsletter – Apr 2020 – Spinal Stabilization and Fusion Systems

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

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