Spinal implant: MAGEC System Model X rods – risk of failure in use (MDA/2020/010)
Manufactured by NuVasive Inc. – risk of end cap separation after implantation.
Action
- Identify and quarantine all affected devices (see details below).
- Follow actions recommended in the manufacturer’s Field Safety Notice (FSN).
- Ensure systems are in place to follow up patients implanted with affected devices.
MHRA has sought expert clinical advice that recommends all patients receive the following additional follow-up to identify end cap separation:
- Anteroposterior X-ray imaging within 3 months of this alert.*
- Advise all patients about the possible complications resulting from this issue as described in the manufacturer’s FSN and what alternative treatment options are available. Each patient should be assessed individually using your own clinical judgement.
- Continue patient monitoring in alignment with the manufacturer’s instructions for use using anteroposterior X-ray imaging instead of ultrasound imaging.
- Report suspected or actual adverse events involving these devices through your local incident reporting system and/or your national incident reporting authority as appropriate: England, Scotland, Northern Ireland, Wales. You should also report directly to manufacturers if your local or national systems do not.
*In all cases, the benefit of ionising radiation screening should be weighed against the risks from radiation exposure on an individual patient basis, in line with the requirements of The Ionising Radiation (Medical Exposure) Regulations 2017.
Action by
- Orthopaedic spinal surgeons
- Paediatric spinal surgeons
- Supplies managers
- Theatre managers
Deadlines for actions
Actions underway: 17/04/2020 Actions complete: 10/06/2020
Medical Device Safety Officers (in England)
Ask the manufacturer to add you to their distribution list for field safety notices (FSNs). This is to help with reconciliation.
Remember
If your organisation receives an FSN from a manufacturer, always act on it. Do not wait for a communication from the MHRA.
Device details
In addition to the manufacturer’s FSN, which details lot numbers of affected products, please refer to the table below. All the products identified in the table were marketed as MAGEC Model X rods.
| Device identifier GTIN | Catalogue number (manufacturer product code) | Product description |
|---|---|---|
| 00812258022624 | PA0684-001 | MAGEC 2 Rod, 4.5mm 90mm Standard |
| 00812258022662 | PA0684-002 | MAGEC 2 Rod, 5.5mm 90mm Standard |
| 00812258022631 | PA0684-003 | MAGEC 2 Rod, 6.0mm 90mm Standard |
| 00812258022631 | PA0684-004 | MAGEC 2 Rod, 4.5mm 90mm Offset |
| 00812258022679 | PA0684-005 | MAGEC 2 Rod, 5.5mm 90mm Offset |
| 00812258022716 | PA0684-006 | MAGEC 2 Rod, 6.0mm 90mm Offset |
| 00812258022600 | PA0684-007 | MAGEC 2 Rod, 4.5mm 70mm Standard |
| 00812258022648 | PA0684-008 | MAGEC 2 Rod, 5.5mm 70mm Standard |
| 00812258022686 | PA0684-009 | MAGEC 2 Rod, 6.0mm 70mm Standard |
| 00812258022617 | PA0684-010 | MAGEC 2 Rod, 4.5mm 70mm Offset |
| 00812258022655 | PA0684-011 | MAGEC 2 Rod, 5.5mm 70mm Offset |
| 00812258022693 | PA0684-012 | MAGEC 2 Rod, 6.0mm 70mm Offset |
| 00812258029265 | PA0684-013 | MAGEC 2 Rod, 5.0mm 90mm Standard |
| 00812258029272 | PA0684-014 | MAGEC 2 Rod, 5.0mm 90mm Offset |
| 00812258029296 | PA0684-015 | MAGEC 2 Rod, 5.0mm 70mm Standard |
| 00812258029289 | PA0684-016 | MAGEC 2 Rod, 5.0mm 70mm Offset |
Problem / background
The manufacturer issued a Field Safety Notice, dated 13 February 2020, to inform users of the potential for the end cap component of affected devices to separate from the housing tube after implantation. The end cap is a threaded component which is designed to prevent the ingress and egress of fluid from the mechanism of the MAGEC System. This component may de-thread after implantation, exposing internal components of the actuator. This could lead to accelerated degeneration of the mechanism and release of titanium alloy wear debris. This issue affects only the MAGEC Model X device generation.
The manufacturer says that affected devices might still distract and/or continue serving as an internal brace despite separation of the end cap. However, the aim of this MDA is to provide additional guidance on the clinical follow-up of patients implanted with affected devices.
Manufacturer contacts
Nuvasive Specialized Orthopedics
Tel: +1 858-909-1800
Distribution
If you are responsible for cascading these alerts in your organisation, these are our suggested distribution lists.
Trusts (NHS boards in Scotland)
CAS and NICAS liaison officers for onward distribution to all relevant staff including:
- Fracture clinics
- Health and safety managers
- Medical directors
- Operating department practitioners
- Orthopaedic surgeons
- Outpatient clinics
- Outpatient theatre managers
- Outpatient theatre nurses
- Paediatric nurse specialists
- Paediatric surgeons
- Paediatric surgery, directors of
- Paediatric wards
- Paediatricians
- Paediatrics departments
- Radiographer superintendents
- Radiographers
- Radiologists
- Radiology departments
- Radiology directors
- Risk managers
- Supplies managers
- Theatre managers
- Theatre nurses
- Theatres
Independent distribution
- Establishments registered with the Care Quality Commission (CQC) (England only)
- Clinics
- Hospitals in the independent sector
- Independent treatment centres
- Private medical practitioners
Please note
CQC and OFSTED do not distribute these alerts. Independent healthcare providers and social care providers can sign up to receive MDAs directly from the Central Alerting System (CAS) by sending an email to: safetyalerts@dmhra.gov.uk and requesting this facility.
Enquiries
England
Send enquiries about this notice to the MHRA, quoting reference number MDA/2020/010 or 2020/002/018/291/002.
Technical aspects
Devices Safety and Surveillance Group, MHRA
Tel: 020 3080 6000
Email: DSS-TM@mhra.gov.uk
Clinical aspects
Devices Clinical Team, MHRA
Tel: 020 3080 7274
Email: dct@mhra.gov.uk
Reporting adverse incidents in England
Northern Ireland
Northern Ireland Adverse Incident Centre, (NIAIC), CMO Group, Department of Health (Northern Ireland),
Department of Health, Social Services and Public Safety
Tel: 028 9052 3868
Email: niaic@health-ni.gov.uk
https://www.health-ni.gov.uk/niaic
To report an adverse incident involving a medical device in Northern Ireland use the forms on our website.
Alerts in Northern Ireland are distributed via the NICAS system.
Scotland
Enquiries and adverse incident reports in Scotland should be addressed to:
Incident Reporting and Investigation Centre (IRIC),
Health Facilities Scotland,
NHS National Services Scotland
Tel: 0131 275 7575
Email: nss.iric@nhs.net
Reporting adverse incidents in Scotland
To report an adverse incident involving a medical device in Scotland, email IRIC to request a webform account. For more information, or if you can’t access the webform, visit the website: how to report an adverse incident
Wales
Enquiries in Wales should be addressed to:
Healthcare Quality Division,
Welsh Government
Tel: 02920 823 624 / 02920 825 510
Email: Haz-Aic@wales.gsi.gov.uk
Reporting adverse incidents in Wales
Report to MHRA through Yellow Card and follow specific advice for reporting in Wales in MDA/2004/054 (Wales).
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