Possible Adverse Effects - DePuy Synthes SPOTLIGHT Manual Del Usuario

The expandable retractor is comprised of four components:
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Stainless steel handle with a rigid arm attachment connection and a lever lock to prevent inadver-
tent collapse or expansion
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Stainless steel modular left blade (various sizes)
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Stainless steel modular right blade (various sizes)
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Stainless steel modular middle blade (various sizes)
The middle blade is assembled to the handle by snapping the two tines on the blade into the receiver
on the underside of the handle. The left and right blades insert into the corresponding receivers on
the handle marked "L" and "R". For instrument assembly and disassembly images please refer to the
surgical technique manual.
The left and right modular blades are offered in both lighted and non‐lighted configurations and the
middle modular blade is non‐lighted. The lighted left and right modular blades are constructed of
stainless steel with proprietary fiber optics in a bonding material. The lighted blades each include
a proprietary fitting for one of the two forked termination ends of the Y cable. Once the Y cable is
attached to both blades, the singular termination end of the Y cable can be plugged into a standard
ACMI light cable. The standard ACMI light cable can then be plugged into a hospital light source in
the surgical suite. The Y cable is constructed of stainless steel, proprietary fiber optics, rigid plastic,
and flexible rubber.
Both the retractor and reusable decortication instruments are supplied non‐sterile and must be
sterilized prior to first use.
INDICATIONS
CAUTION: U.S.A. Law restricts this device to sale by or on the order of a physician.
The SPOTLIGHT Access System and SPOTLIGHT PL are intended to provide the surgeon with
minimally invasive surgical access to the spine by ensuring the placement/positioning of the port or
retractor, down to the posterior and posterolateral bony spinal elements. These ports and retractors
provide access to the spinal site which can be visualized using a microscope or loupes, and through
which surgical instruments can be manipulated.
CONTRAINDICATIONS
Clinical and/or radiographic determinations that exclude the use of the SPOTLIGHT Access
System include:
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Infection-overt or active
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Fever > 101°F (38°C)
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Local inflammatory signs

POSSIBLE ADVERSE EFFECTS

Risks possibly associated with the use of the SPOTLIGHT Access System are similar to those
associated with any surgery to the planned area of instrument use. The most frequently stated risks
are bleeding, damage to the surrounding soft tissue and infection. Each of these risks has also
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