Surgical Skull Clamps Device Slippage
After having received over 1,000 medical device reports, the U.S. Food and Drug Administration issued a Safety Communication warning of the risk of skull clamps (also known as “neurosurgical head holders”) to slip off of the patient’s head during or before surgery. From January 2009 to January 2016, this error resulted in more than 700 injuries.
What are skull clamps?
A skull clamp is part of a neurological head holder system used to hold the patient’s head position during surgical procedures, and may also include a head holder frame that attaches to the operating table, neurosurgical head hold stabilization components, or skull pins.
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What injuries may occur due to skull clamp slippage?
In the case of skull clamp slippage, the unintended patient movement during surgery may result in injuries including:
- skull fractures,
- facial injuries (bruises and cuts),
- deep cuts (lacerations), and
- blood clots (hematoma).
The FDA Safety Communication also warns that “unintended patient movement has compromised procedures dependent upon head immobilization causing inaccurate stereotaxic navigation and delayed, prolonged, or halted surgical procedures.”