AUDIENCE: Surgery, Neurology, Orthopedics, Otolaryngology
ISSUE: 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.
BACKGROUND: A neurosurgical head holder (skull clamp) system is a device used to secure the patient’s head position during surgical procedures. The system may include a head holder frame that attaches to the operating table, skull clamp, neurosurgical head hold stabilization components, skull pins and other accessories.
RECOMMENDATION: Based on current information, the FDA believes the overall benefits of these devices continue to outweigh the risks. However, health care providers 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. Read the full FDA Safety Communication for the complete list of recommendations.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
[02/25/2016 - Safety Communication - FDA]