FDA advises doctors to be vigilant of slippage during surgery
The Food and Drug Administration (FDA) recently admitted is received over 1,000 medical device reports (MDR) between 2009 and 2016 concerning skull clamps. Of the 1,000 MDRs, over 700 involved cases of injury, some serious.
Injuries associated with malfunctioning skull clamps include:
- Skull fractures,
- Facial injuries (bruises and cuts)
- Deep cuts (lacerations)
- Blood clots (hematoma)
Other issues with the skulls clamps resulted in inaccurate stereotaxic navigation, a complex medical procedure requiring precise incisions to take biopsies or perform surgery of the brain.
What are skull clamps?
Skull clamps are medical devices used to secure a patient’s head during surgery. The device is usually comprised of a head holder attached to an operating table, the skull clamp which stabilizes the patient’s head, and skull pins to keep the head steady.
Skulls clamps are typically used in:
- Neurosurgery (brain and spinal cord procedures)
- Otolaryngology (ear, nose, and throat procedures)
- Orthopaedics (musculoskeletal system)
The FDA’s MDRs do not find correlations between any specific brand of skull clamp or surgical procedure. Patients who believe they were harmed by a defective or improperly secured skull clamp should consider speaking to an attorney about their case.
What is the problem with skull clamps?
According to the FDA, the main issue with skull clamps is slippage or unintended movement of the patient’s head during surgery. Reasons for the incidents vary but include such factors as:
- Mechanical failure of the skull clamp
- Issues with placement of the skull clamp
- Thickness and bone quality of the patient’s skull
- Lack of maintenance
With hundreds of adverse medical events tied to this device, it is disconcerting why the FDA waited so long to issue a release on the subject. While hundreds of patients were injured over the years, the FDA remained silent.
My head slipped out of a skull clamp during surgery, can I file a lawsuit?
If you or a loved one were hurt because your head slipped out of a skull clamp during surgery, you might be entitled to substantial compensation. While each case is different and there are no guarantees a plaintiff may win a lawsuit or be awarded damages, the law does give victims legal remedy to recover for their damages.
For a free case review of your claim, contact The Cochran Firm, D.C. and speak to an attorney. Our medical malpractice attorneys and defective medical device lawyers have years of experience helping victims in their times of need and may be able to help you do the same.
Fill out an online contact form with the details of your case or call our office directly at 202-682-5800 during business hours or at 1-800-THE FIRM (843-3476) to reach us 24 hours a day. Strict time deadlines apply when filing claims so please contact us at your earliest convenience and preserve your legal rights.