The problem affects Mazor X systems with posititioner Type II, the company said in an urgent field safety notice issued in the U.K. It wasn’t immediately clear if the problem that causes the system to detach affects units distributed elsewhere. No injuries have been reported, although Medtronic said it has received seven complaints of this issue occurring since Nov. 13, 2019. Possible injuries might include hemorrhage, hematoma, bleeding or fracture(s), the company said.
In the field notice, Medtronic described the problem thus:
“During pre-operative preparation, the Mazor X surgical system is raised and mounted over the OR table with the aid of the manipulator, which is the on-board automated lifting mechanism. This enables raising of the surgical system over the OR table and mounting it onto the bed frame. The positioner provides a mechanism for rigid locking of the surgical system on the OR table, after disconnecting it from the manipulator.
“Medtronic is aware of instances where the Mazor X positioner Type II has unexpectedly released from the OR table after being securely attached. Investigation has determined that the occurrences are due to the potential for slight air leakage over time within the pneumatic system resulting in a gradual decrease in the positioner Type II latching device holding force. After time, this can result in the surgical system to release from the bed frame.”
In a separate statement to MassDevice, the company described Mazor X as indicated for precise positioning of surgical instruments during general spinal surgery.
“In December of 2019, Medtronic initiated a medical device correction related to the Mazor X surgical system,” company spokesman David Young said in an email. “Medtronic received complaints — none of which involved patient injuries — of the surgical system having issues maintaining a rigid connection to the operating room table. This could result in the surgical system slowly descending toward the user or patient.”
The company said reports are rare, but it has a mitigation to permanently correct the issue while offering instructions to all customers on how to prevent this from happening.
Medtronic closed on its $1.7 billion purchase of Mazor Robotics and its robot-assisted surgery platform for the spine in late 2018. A month later, Medtronic launched its Mazor X Stealth robotic-assisted spinal surgical platform in the U.S.
The company is advising users that leaving the locking lever in the open position will maintain pneumatic pressure within the system and keep it from detaching and falling.
“At Medtronic, patient safety is our priority,” Young said. “We take this potential risk seriously, and we are working to ensure all Medtronic customers are fully aware of the risk and associated mitigations.”
MDT was trading down 0.12% at $114.75 in mid-afternoon trading.