Indication For Use
The MAYFIELD 2 Skull Clamp is placed on the patient's skull to hold their head and neck securely in
a particular position when rigid fixation is desired. The Skull Clamp is indicated for use in open and
percutaneous craniotomies as well as spinal surgery when rigid fixation is necessary.
The MAYFIELD 2 Skull Clamp is NOT Radiolucent.
Failure to read and follow the instructions furnished in this product insert may
result in serious patient injury.
The Skull Clamp must be applied along the center line of the patient's head with
pins entering the skull perpendicularly (See Table 1). Failure to properly position
the Skull Clamp on the patient's head could result in patient injury such as scalp
laceration due to skull pin slippage. Failure to properly position patient and to fully
secure all adjustment positions of the Skull Clamp or any support device may result
in patient injury.
It is cautioned that only MAYFIELD products have been validated for use with other
MAYFIELD products. Integra cannot advise whether other suppliers' products
would function properly with the MAYFIELD line of products. Integra does not offer
warranty protection when a non-MAYFIELD brand product is used with a MAYFIELD
branded product.
Do not alter the design of the device in part or whole as serious patient injury could
result.
Do not use Skull Clamps to exert excessive traction during a procedure. Patient
injury could result.
Skull Clamps are not intended for use in or near the vicinity of a strong magnetic
field (MRI).
This device is NOT Radiolucent.
WARNING!
WARNING!
Page 3