7 of 108
7. Nerve damage due to surgical trauma or presence of
the device. Neurological difficulties including radicular
pain, tethering of nerves in scar tissue, muscle weak-
ness, and paraesthesia.
8. Vascular damage could result in catastrophic or fatal
bleeding. Malpositioned implants adjacent to large
arteries or veins could erode these vessels and cause
catastrophic bleeding in the late post-operative period.
9. Dural tears experienced during surgery could result in
the need for further surgery for dural repair, a chronic
CSF leak or fistula, and possible meningitis.
10. Bursitis.
11. Paralysis.
12. Screw back-out, possibly leading to implant loosening,
and/or reoperation for device removal.
13. Damage to lymphatic vessels and/or lymphatic fluid
exudation.
14. Spinal cord impingement or damage.
15. Fracture of bony structures.
16. Degenerative changes or instability in segments adja-
cent to fused vertebral levels.
17. Death.
MAGNETIC RESONANCE (MR)
COMPATIBILITY
The SUMMIT SI Occipito-Cervico-Thoracic (OCT) System
and MOUNTAINEER
OCT Spinal System implants have
not been evaluated for safety and compatibility in the MR
environment. The MOUNTAINEER
OCT Spinal System
implants have not been tested for heating or migration in
the MR environment.
SONGER
®
is a registered trademark of Pioneer Surgical
Technology.
LIMITED WARRANTY AND DISCLAIMER
PRODUCTS FROM DEPUY SYNTHES PRODUCTS, INC.
ARE SOLD WITH A LIMITED WARRANTY TO THE ORIGINAL
PURCHASER AGAINST DEFECTS IN WORKMANSHIP
AND MATERIALS. ANY OTHER EXPRESS OR IMPLIED
WARRANTIES, INCLUDING WARRANTIES OF MERCHANT-
ABILITY OR FITNESS, ARE HEREBY DISCLAIMED.
IF MORE THAN TWO YEARS HAVE ELAPSED BETWEEN
THE DATE OF ISSUE/REVISION OF THIS INSERT AND
THE DATE OF CONSULTATION, CONTACT DEPUY
SYNTHES SPINE FOR CURRENT INFORMATION AT
+1-800-365-6633 OR AT +1-508-880-8100.
MATERIAL
MATL
SYMBOL TRANSLATION
A/T ACROFLEX
®
/Ti
ACROFLEX
®
/Titanium
A AI
Aluminum
A/P Al/PL
Aluminum/Plastic
B/R Ba/RADEL
®
Barium/RADEL
®
Ba/PEEK
Barium Sulfate (BaSO
4
)/
PEEK Polymer
CaP
CALCIUM PHOSPHATE
Calcium Phosphate
CM CoCrMo
Cobalt Chromium
Molybdenum
CMTC
CoCrMo/Ti/CALCIUM
PHOSPHATE
Cobalt Chromium
Molybdenum/Titanium/
Calcium Phosphate
CoNiCrMo
Cobalt Nickel
Chromium Molybdenum
F FOAM
Foam
HA
Hydroxyapatite
NiTi Ni/Ti
Nickel/Titanium
PL
Plastic
SRSI
SS/RADEL
®
/SILICONE
Stainless Steel/RADEL
®
/
Silicone
SRSN
SS/RADEL
®
/
SILICONE/Ti Al Nitride
Stainless Steel/RADEL
®
/
Silicone/Titanium
Aluminum Nitride
SS/RADEL
®
/
SILICONE/Ti Nitride
Stainless Steel/RADEL
®
/
Silicone/Titanium Nitride
SRTA
SS/RADEL
®
/Ti Al Nitride
Stainless Steel/RADEL
®
/
Titanium Aluminum Nitride
STA SS/Ti Al Nitride
Stainless Steel/
Titanium Aluminum Nitride
S/U SS/ULTEM
Stainless Steel/Ultem
T Ti
Titanium and its alloys
S/R SS/RADEL
®
Stainless Steel/RADEL
®
R/T
POLYOLEFIN RUBBER/Ti
Polyolefin Rubber/Titanium
T/A Ti/Al
Titanium/Aluminum
Ti/CoCrMo
Titanium/Cobalt
Chromium Molybdenum
P/F PL/FOAM
Plastic/Foam
PY
Polyester
PEEK/C
PEEK/CARBON
FIBER COMPOSITE
Polyether Ether Ketone/
Carbon Fiber Composite
PEEK OPTIMA
®
Polyether Ether Ketone
P POLYMER
Polymer
P/CM PE/CoCrMo
Polyethylene/Cobalt
Chromium Molybdenum
P/C
POLYMER/CARBON
FIBER COMPOSITE
Polymer/
Carbon Fiber Composite
Si/NITINOL
Silicone/Nitinol
S SS
Stainless Steel
S/A SS/Al
Stainless Steel/Aluminum
SBR SS/Ba/RADEL
®
Stainless Steel/Barium/
RADEL
®
S/P SS/PHENOLIC
Stainless Steel/Phenolic
S/PL SS/PL
Stainless Steel/Plastic
LOT
LOT NUMBER
REF
REF
CATALOG NUMBER
QTY
QUANTITY
SZ
SIZE
MADE IN
MADE IN
NTI
NEURAL TISSUE
INSTRUMENT
IOM
NEUROMONITORING
INSTRUMENTS
Federal (USA) law
restricts this device
to sale by or on the
order of a physician
DO NOT RESTERILIZE
T2
T1
Lower Limit of
temperature = T1
Upper Limit of
temperature = T2
25°C
STORE AT ROOM
TEMPERATURE
KEEP AWAY FROM
SUNLIGHT
SINGLE USE
ATTENTION.
SEE INSTRUCTIONS
FOR USE
PACKAGE CONTAINS
FLAMMABLE LIQUID
DO NOT USE
IF PACKAGE IS
DAMAGED
MSR
MEASURING DEVICE
STERILE
STERILE
STERILE A
Sterile medical device
processed using
aseptic technique
STERILE R
STERILIZATION BY
IRRADIATION
STERILE EO
STERILIZATION BY
ETHYLENE OXIDE
LATEX FREE
LATEX FREE
NON
STERILE
NONSTERILE
NONSTERILE
MANUFACTURER
DATE OF
MANUFACTURE
US REP
US REPRESENTATIVE
EC REP
AUTHORIZED
EUROPEAN
REPRESENTATIVE
DIST
DISTRIBUTED BY
XXXX-XX
USE BY
Ti/HA
Titanium/Hydroxyapatite
Ti/UHMWPE/HA
Titanium/Ultra-High
Molecular Weight
Polyethylene/Hydroxyapatite
SS/Ti
Stainless Steel/Titanium
SS/Al/SILICONE
Stainless Steel/
Aluminum/Silicone
SS/SILICA GLASS
Stainless Steel/Silica Glass
SS/SILICA GLASS/
PL/SILICONE
Stainless Steel/Silica Glass/
Plastic /Silicone
SS/SILICA GLASS/
RADEL
®
/SILICONE
Stainless Steel/Silica Glass/
RADEL
®
/Silicone
SS/SILICA GLASS/
SILICONE
Stainless Steel/
Silica Glass/Silicone
S/SI SS/SILICONE
Stainless Steel/Silicone
SS/WC/SILICONE
Stainless Steel/Tungsten
Carbide/Silicone
W/C
Tungsten Carbide
