The FDA has received more than 1,000 medical device reports associated with the slippage, or movement, of a skull clamp before and/or during surgical procedures, resulting in more than 700 injuries from January 2009 to January 2016.
While they still believe the overall benefits of these devices continue to outweigh the risks, they are advising healthcare providers that they should be aware of patient-specific characteristics, techniques for safe use and maintenance of neurosurgical head holder systems to prevent skull clamps from slipping before and/or during surgical procedures.
The FDA’s review of medical literature and analysis of currently available data suggests that device slippage is not specific to any manufacturer or brand of devices.
The recommendations were relayed through a recent safety communication.
Reported injuries included skull fractures, facial injuries consisting of bruises and cuts, lacerations and blood clots.