CD HORIZON SOLERA 5.5/6.0 (MEDTRONIC SOFAMOR DANEK USA, INC.) — Malfunction
A malfunction event was reported involving the CD HORIZON SOLERA 5.5/6.0 spinal system manufactured by Medtronic Sofamor Danek USA, Inc. The source documents the event under the malfunction category without detailing the specific failure mode.
This notice affects Medtronic Sofamor Danek USA, Inc., orthopedic surgeons utilizing spinal fixation systems, and regulatory/QA professionals responsible for post-market surveillance of class II or III implantable spinal devices.
The reporting of a malfunction for an established spinal fixation system suggests a potential deviation from expected performance specifications. For regulatory professionals, this type of entry indicates a need to monitor for trends in device failure that may trigger further corrective actions or labeling updates. The limited detail in the source implies a routine but necessary safety filing under 21 CFR 803.
Regulatory and QA teams should review internal complaint logs for similar malfunctions involving spinal constructs and ensure that Post-Market Surveillance (PMS) reporting timelines are strictly adhered to. Clinical teams should monitor for issues related to component integrity in the CD HORIZON SOLERA 5.5/6.0 systems.
Event type: Malfunction. Device: CD HORIZON SOLERA 5.5/6.0 by MEDTRONIC SOFAMOR DANEK USA, INC..
Open in openFDA / FDA.gov