PMCF Neo Pedicle Screw and Cage Systems

Fusion With the Neo Pedicle Screw and Cage Systems: A Post Market Clinical Follow-up Study

The objectives of this clinical observational study is to evaluate the safety and efficacy (performance) of the Neo Pedicle Screw System™ and the Neo Cage System™ interbody fusion device. To demonstrate non-inferiority of safety and function to an historical control from the published medical literature on competitive devices.

Inclusion criteria:

• Patient has undergone or is intended to undergo surgery with the Neo Pedicle Screw System™, standalone or in combination with the Neo Cage System™, for any of the approved indications as defined in the respective labelling
• Patient has participated in or is willing to participate in the routine postoperative follow-up program
• Patient is willing to provide written informed consent

Exclusion criteria:

• Patient is under the age of 18 or skeletally immature
• Patient had or has a contraindication to surgery or to any of the implant systems used in the study, as defined in the respective labelling