Defective Spinal Rods
Once again, the lack of legislative safeguards in place for medical devices (as opposed to medicines) here in Ireland is brought into focus by the publication of an “urgent” Field Safety Notice Field Safety Notice Field Safety Notice by manufacturers NuVasive dated the 13th February 2020.
The purpose of the Notice was to inform healthcare providers caring for patients who have had MAGEC System Model X rods inserted during spinal fusion surgery for scoliosis.
Scoliosis is a structural lateral curvature of the spine and affects around four children per thousand.
The MAGEC system comprises a magnetically distractible spinal rod implant and an external remote controller which lengthen the rod; this system avoids repeated surgical lengthening.
The Notice states that post-implantation separation of an actuator end cap component has been observed in MAGEC System Model X rods, approximately 0.5 % of them. It goes on to advise that separation of the end cap may expose internal components of the actuator, which could lead to “hastened degeneration of the internal components and egress of Titanium alloy wear debris and resultant localised tissue discoloration.” It recommends that surgeons perform routine clinical follow up and discuss potential clinical implications and risks with patients who received affected rods. The decision to remove the device should be made by the physician in consultation with the patient and/or family.
We understand that the number of children affected is under twenty and hopefully, that is correct. We also understand that these patients are being contacted presently by their treating surgeons.
There is no doubt but that medical devices such as these Titanium rods can be, and are, life changing but there is a need for stronger legislation of the medical device industry in Ireland. Indeed, we have highlighted this need in previous blogs.
Contact us at Cantillons Solicitors at +353 (0) 21 4275673 or firstname.lastname@example.org if you would like more information.
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In her twenty years as a practising solicitor, Karen has worked with a number of leading law firms in Limerick and Cork where she has acquired extensive experience in all areas of the law, with a particular expertise in medical negligence cases.
Karen has represented clients effectively in many forums including the District Court, Circuit Court, High Court, Employment Tribunals and Coroner’s Court. She has acted for, and advised, State Bodies in respect of all areas of the law to include childcare law; employment issues; food safety and health and safety issues.
Karen joined Cantillons Solicitors in November 2009 and works in the Medical Negligence Department practising clinical negligence litigation. She is expertly assisted by Patricia Sisk and April Wiseman, Legal Assistants.
She is very proud to be a member of the medical negligence team which has been involved in precedent-setting cases since 1980 and which received the inaugural award of Litigation Team of the Year, National Irish Bank Law Awards in 2012.
Karen regularly attends international conferences in order to add to her pool of her experts and ensure access to the world’s best. She is also regularly asked to speak at national and international conferences concerning medico-legal issues. She is a regular speaker at the annual Medical Law Conference; giving presentations on healthcare law, practice and procedure to employees in the healthcare section and fellow lawyers. This lecturing experience means that Karen has an excellent grasp of law in theory as well as in practice.
Karen has featured on national television and on local and national radio in relation to this specialised area of medical negligence litigation.She has been commissioned to write opinion pieces on topical issues in the medical negligence area, published in national newspapers. Notably, she first highlighted in the Irish Examiner, the Minister for Health’s failure to introduce a statutory Duty of Candour- a legal requirement for medical staff, nurses and management to tell patients and their families if a mistake has been made which adversely affects the patient’s health – despite the Minister’s promise to do so.
Karen also writes a weekly column in a local daily newspaper, the Evening Echo, addressing reader’s legal queries. This column appears in Monday’s edition of the paper.
Karen has developed real expertise in her field and has shown great dedication in pursuing complex injury cases to settlement.
Karen gets referrals from patients nationwide. She represents her patients with determination and compassion.
- BCL Honours 1992
- Admitted to the Roll of Solicitors in Michaelmas 1996
- Former Secretary of Limerick Bar Association
- Former member of the Litigation Committee of the Law Society of Ireland
- Member of the Medical Injuries Alliance
- Member of Action Against Medical Accidents (AvMA)