The Mazor X system is a device that precisely positions surgical instruments or implants during spine and brain surgery.
Medtronic said the detachment issue is likely due to slight air leakage into the device’s pneumatic system and could result in the surgical system falling onto a patient, which could cause blunt injury leading to hemorrhage, hematoma, bleeding or fractures, according to Medtech Dive.
In an urgent field safety notice sent to healthcare providers in December, Medtronic said that it had received seven complaints of the detachment issue as of Nov. 13, though none involved patient injuries.
The company offered modified instructions to safely set up the system to avoid the hardware detachment issue and said it is working on a permanent solution to correct the issue.
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