Allez Spine’s Laguna Pedicle Screw System, a 510(k) spinal fixation system substantially equivalent to Medtronic’s CD Horizon spinal system, is adulterated because the firm made significant changes to the device without submitting the requisite premarket notification, according to an FDA warning letter.
The modifications made to the Laguna system — which include technical locking nut changes, treading profile and sterilization parameter changes — could increase the risk of biomechanical failure, and no PMA application or investigational device exemption for the modified device is on file, the Aug. 8 warning letter says.
Allez Spine told MQN it plans to release a revised design of the system, which would have a new 510(k).
The warning letter, recently posted on the FDA’s website, also cites the company for design control procedures, which were not established prior to the first sales of the Laguna system.
A retrospective design plan to implement a design-control procedure also was not completed, the letter says. The warning letter can be accessed at www.fda.gov/foi/warning_letters/s6925c.pdf.