ANTERALIGN¿ Spinal System with Titan nanoLOCK¿ Surface Technology

Description of Event or Problem

Information was received from multiple sources (Manufacturer Representative, User Facility) regarding a device used for a Spinal therapy. It was reported that the trial component was really tight on the inserter and was very difficult to remove, which was noticed during clean up. It was also reported that the elevator and distractors were sticking on the navlock, making them very hard to take on and off. There was no patient involved.

Additional Manufacturer Narrative

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.