Skull Clamp Slippage during Brain Surgery Reported to FDA

Contact our law firm about a lawsuit if you or a loved one have been injured during a surgical procedure involving head holders (skull clamps) used during neurosurgery (brain surgery).

The U.S. Food and Drug Administration (FDA) has issued a warning regarding the dangers posed by the improper use and maintenance of neurosurgical head holders (skull clamps) used to immobilize patients’ heads during surgical procedures.

From January 2009 through January 2016, the FDA gathered more than 1,000 medical device reports describing the slippage of skull clamps during surgery. More than 700 patients were injured as a result, sustaining injuries including:

  • skull fractures
  • hematomas (blood clots)
  • lacerations
  • facial cuts
  • bruises.

In many cases, the slippage of the device also resulted in prolonged or halted surgical procedures.

The FDA has ascertained that the skull clamps themselves – produced by different manufacturers – are not faulty if they are adequately maintained and used according to their directions/specifications. Slippage occurs when surgeons and / or other medical professionals use the devices improperly or fail to examine them for signs of wear. According to the FDA:

The causes of skull clamps slipping before and/or during surgical procedures are multifactorial, and may include device performance (e.g., mechanical failure of the skull clamp), device application (e.g., issues with placement of the skull clamp and/or accessories), patient specific characteristics (e.g., thickness and bone quality of the patient’s skull) and lack of maintenance. Some of these risks can be mitigated through device placement considerations, proper use and proper device maintenance. (1)

What Are Neurosurgical Head Holders (Skull Clamps)?

Neurosurgical head holders systems, which secure patients’ heads during brain surgery, are complex medical devices comprised of a head holder frame that attaches to the operating table, the skull clamp itself, neurosurgical head hold stabilization components, and skull pins.

To prevent slippage, the FDA recommends that surgeons:

  1. Follow the manufacturer’s recommendations for cleaning, maintenance, and replacement;
  2. Carefully examine the device for damage before and after each use;
  3. Apply a degree of force to the device prior to fixation to test its stability;
  4. Observe the correct procedures for positioning the patients, including supporting the patient’s head and neck while applying/removing the device, avoiding positioning the skull pins over uneven or fragile bone areas, and taking particular caution when placing pins in pediatric patients.

Do You Have a Lawsuit?

Contact attorney Fred Pritzker if you want information on how to sue for compensation and justice. Our national product liability law firm has secured multi-million dollar settlements for our clients, including $45 million for clients injured by another product. You can contact us by calling 1-888-377-8900 (toll-free) or by using our free consultation form.


  1. Press Release. “Neurosurgical Head Holders (Skull Clamps) and Device Slippage: FDA Safety Communication.” U.S. Food and Drug Administration. Web. 25 Feb. 2016.

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