- Munich, Germany-based medtech Brainlab AG is recalling the spine and trauma 3D software used with its navigation system designed to help surgeons place tools and implants in minimally invasive procedures.
- The software could display inaccurate information during a procedure that may prevent the surgeon from safely navigating surgical tools inside the patient, resulting in serious injury or death, FDA said in a notice on the recall.
- The recalled software is the Brainlab Spine & Trauma 3D Navigation 1.0, manufactured and distributed between May 2018 and February 2019. A total of 60 devices are being recalled in the United States.
Brainlab plans to stop distributing the spine and trauma navigation software as soon as an updated version is released, FDA said. Those with the current software are advised to follow certain steps for operation outlined in FDA's communication.
Brainlab has run into problems with inaccuracies in a navigation system before. In 2013, it recalled its cranial image-guided surgery system due to potential inaccuracies in the display, compared to patient anatomy. The company updated that recall in 2015.
In 2017, FDA issued a warning to healthcare providers that navigational accuracy errors may occur with stereotaxic navigation systems in general, in specialties including otolaryngology, neurosurgery, orthopedics and oral surgery. The agency said it was aware that some surgeons had experienced such errors, and they may have led to patient deaths or injury, or inaccurate or prolonged medical procedures.
At the time, FDA said it had not determined that any one system carried greater risk than others, and it believed the benefits of the devices still outweighed the risks. The agency said it was working with manufacturers to ensure labeling included clear instructions on how to minimize issues.
FDA provided a link to the 2017 communication in the new Brainlab recall notice.
Stereotaxic devices have a computer system that uses imaging such as CT and MRI to guide surgeons' placement of specialized instruments and implants before and during procedures. The devices work by registering landmarks between the patient's anatomy and radiographic images. During a procedure, the surgeon is guided by optical, electromagnetic or other tracking methods that provide real-time visualization of the instruments' position overlaid on the patient's images.
Besides Brainlab, companies making stereotaxic systems include Medtronic, Germany's Inomed, and Integra LifeSciences through its 2005 acquisition of Radionics division of Tyco Healthcare.
In addition to the spine and trauma navigation system, Brainlab makes systems for neurosurgery, orthopedic procedures, and ear, nose and throat surgery.