16. Bone graft donor site pain, fracture, and/or delayed wound
healing
17. Restriction of activities
18. Lack of effective treatment of symptoms for which the sur-
gery was intended
19. Death
Preoperative
1.
Only patients that meet the criteria described in Indications
section and do not have any conditions included in the Con-
traindication section of this package insert should be se-
lected for surgery.
2.
Implants of this system must be handled and stored to avoid
damage. Implants should be protected from damage includ-
ing scratches, nicks and corrosive environments.
3.
The surgeon should be instructed on the proper use of in-
struments and implants.
4.
All implants and instruments of the system must be inspect-
ed for damage, cleaned, and sterilized prior to use. Compo-
nents of other systems should not be used with the
4
S
Spinal System.
38
4
S
Spinal System