MAGEC® System Instructions for Use Update

A Dear Healthcare Professional Letter has been issued by NuVasive South East Asia Pte Ltd, as a follow up to the earlier communication issued in September 2021, to inform healthcare professionals of updates to the MAGEC^® System Instructions for Use (IFU). The changes include the updated intended use for skeletally immature patients <10 years of age with severe progressive spinal deformities associated with or at risk of Thoracic Insufficiency Syndrome, and a shortened implantation duration from six to two years to reduce the risk of adverse events. Healthcare professionals are advised to review the updated IFU document, consult their patients who are currently implanted with MAGEC^® System rod(s) beyond two years or beyond the updated intended use population on these updates and assess care decisions in collaboration. Healthcare professionals are also reminded to follow-up with all MAGEC^® patients at a minimum of once every six months. Please refer to the letter for details.

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of these letters can be found in the MOH Alert System, which is accessible via the Health Professionals Portal (HPP), a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://hpp.moh.gov.sg and follow the procedures below to access the MOH Alert system.

Step 1: Select your profession under ‘For Healthcare Professionals’.

Step 2: Click on ‘Useful links’.

Step 3: Click on ‘MOH Alert’ and log in via Singpass.

Step 4: Click on ‘Drug Alerts’ or ‘Med Device Alerts’ to view the DHCPLs.