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More than 700 patients have been injured since 2009 when skull clamp systems used to immobilize the head moved or slipped during surgical procedures, the FDA has reported.
The injury accounts were collected from more than 1000 medical device reports that described unintended patient movement during surgery. Injuries included skull fractures; facial cuts, bruises, and lacerations; and blood clots. The FDA said skull clamp slippage isn’t specific to any manufacturer or brand of devices (http://1.usa.gov/1Q5KV9P).
Voelker R. Skull Clamps Are Slipping. JAMA. 2016;315(13):1328. doi:10.1001/jama.2016.2765