ANTERALIGN¿ Spinal System with Titan nanoLOCK¿ Surface Technology

Description of Event or Problem

Information was received from user facility via manufacturing representative regarding a product identified during an event. It was reported that product unknown malfunction. Patient involvement was unknown. No further complications were reported/anticipated. Additional information was received that for Rongeur -the screw on the handle was sticking out. Hammered the screw back then fixated it with Oife tape before and was used. It worked without any issues. When inserter was used to grasp the cage, the screw portion did not engage properly and felt wobbly. When another inserter was used, it could be grasped.

Additional Manufacturer Narrative

H3: Product Analysis #844189451: Since this product is outside the scope of repair service, no repair will be performed. 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.