Quality hold on MAGEC® System
Healthcare professional
Industry member
Medical devices
14 September 2021
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A Dear Healthcare Professional Letter has been issued by NuVasive South East Asia Pte Ltd to inform healthcare professionals of a quality hold that has been placed on the MAGEC® system. This is due to potential gaps identified in its biocompatibility and ongoing corrective actions in response to a Technical File review by the European Union authority, Medizinprodukte GmbH (DQS). In view of this, the MAGEC® system is currently unavailable in Singapore for new implants. Healthcare professionals are advised that prophylactic removal of implanted functioning devices is not recommended, and any treatment decisions are to be made in consultation with the patient and/or family. Healthcare professionals are also reminded to follow-up with all MAGEC® patients according to the clinical guidelines set out in the instructions for use, such as using appropriate postoperative procedure to assess the MAGEC® system by x-ray imaging whenever the device is adjusted or 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.
