FDA warns of neurosurgical head clamp slippage

The FDA today released a safety communication warning about slippage associated with skull clamps moving before and during surgical procedures, with 700 reported injuries associated with such failures.

The devices, neurosurgical head holder systems, are designed to secure the patient’s head during surgical procedures. The devices may include a head holder frame that attaches to an operating table, skull clamp, neurosurgical head hold stabilization components, skull pins and other accessories.

Between January 2009 and January 2016, the FDA reports it received more than 1,000 medical device reports of slippage before or during procedures, with a total 700 injuries among those reported, according to the FDA’s press release.

Unintentional patient movement is described in the reports, resulting in injuries including skull fractures, facial injuries, deep cuts and blood clots. The FDA reported that the movement also compromised procedures dependent upon head immobilization resulting in inaccurate stereotaxic navigation and delayed, prolonged or halted surgical procedures.

The FDA said that device slippage is not specific to a particular manufacturer or device, and that the causes of slippage are multifactorial and could include device performance, application, patient specific characteristics and lack of maintenance.

The agency urged facilities using such devices to follow manufacturer’s recommendations for cleaning, maintenance and replacement, and to inspect the systems before and after each use.

While the federal watchdog received a number of adverse events report, it said it believes that, based on current information, that the overall benefits of the devices outweighs the negatives.

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