ANTERALIGN¿ Spinal System with Titan nanoLOCK¿ Surface Technology

Description of Event or Problem

Information was received from healthcare provider (HCP) via a manufacturer representative regarding a Patient having Spinal therapy to L3/4 for Adult spinal deformity. It was reported that the cage backed out, additional impaction may be performed on the 13th. There was unknown patient symptoms reported. There were no further complications reported regarding the event. Additional information received that the Images were reviewed during the second-stage posterior surgery, and since the cage had not changed position from what was reported previously, the procedure was completed with posterior fixation only, without any additional intervention. Additional information received that there was no patient symptoms reported as a result of this event.

Additional Manufacturer Narrative

G2: Country of origin is Japan E1: Initial reporter details are Unknown. Medtronic submits this report to comply with FDA regulations 21 CFR Parts 4 and 803. Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report. This report does not constitute an admission or a conclusion by FDA, Medtronic, or its employees that the device, Medtronic, or its employee caused or contributed to the event described in the report. Any required fields that are unpopulated are blank because the information is currently unknown or unavailable. Medtronic will submit a supplemental report if additional relevant information becomes known.