|A safety communication has been posted regarding|
Neurosurgical Head Holders (Skull Clamps) and Device Slippage.
From January 2009 to January 2016, the FDA received more than 1,000
medical device reports (MDRs) associated with the slippage or movement
of a skull clamp before and/or during surgical procedures, resulting in more
than 700 injuries. These reports describe unintended patient movement
during surgical procedures that resulted in injuries including skull fractures,
facial injuries (bruises and cuts), deep cuts (lacerations), and blood clots
(hematoma). Additionally, unintended patient movement has compromised
procedures dependent upon head immobilization causing inaccurate
stereotaxic navigation and delayed, prolonged, or halted 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 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.
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