Spinal Frontiers · Clinical Practice · Report a Device Problem
Where to report a failed or faulty spinal implant, instrument or system, in the UK, Europe, the US and elsewhere.
Every country has an official route for reporting a problem with an implant, instrument or system. Reporting helps regulators spot patterns early, and recalls often start with a single surgeon's report.
Tell the manufacturer as well: under EU, UK and US rules they must record, investigate and, where needed, report serious incidents themselves.
Commission page linking to PDF lists of each country's medical device competent authority and its vigilance contact point, useful for finding where to report in countries not listed here.
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Healthcare professionals who use or operate devices, and hospital technical safety officers, report serious incidents to BASG through its online incident form.
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Healthcare professionals, hospitals and patients can notify incidents with medical devices to the FAMHP materiovigilance service; the agency publishes 'Who should notify?' and 'How should incidents be notified?' pages for each type of reporter.
Reporting details not yet confirmed: check the regulator's page before relying on them.
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The BDA 'Safety system' page provides downloadable Word forms, including an incident/potential incident notification form under Article 104 of the Medical Devices Act and the manufacturer incident report. General contact: bda@bda.bg, +359 2 8903555.
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Healthcare professionals, users and patients can report adverse events with medical devices to HALMED on its form for healthcare professionals, users and patients (Word document on the HALMED website). Manufacturers use the EU manufacturer incident report form.
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As an EU member state, Cyprus must accept reports of suspected serious incidents from healthcare professionals, users and patients under EU MDR Article 87(10). The Ministry of Health publishes field safety notices on moh.gov.cy.
Reporting details not yet confirmed: check the regulator's page before relying on them.
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Healthcare providers report suspected adverse incidents with medical devices on SÚKL's online form for healthcare providers. Manufacturers use separate online forms. The urgent 24/7 address is urgent@sukl.gov.cz.
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Healthcare professionals, hospitals and self-employed health professionals are obliged to report serious and suspected serious incidents, using the 'Healthcare professional: Report here' online form. Patients and relatives have their own online form.
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Healthcare professionals and users should report a device problem to the manufacturer first. They may also report the incident to Ravimiamet, which is voluntary for them. Contact: Nooruse 1, 50411 Tartu, +372 737 4140.
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Professional users must report incidents with medical devices both to Fimea and to the manufacturer, authorised representative, importer or distributor.
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Hospital and clinic staff report device incidents through their establishment's local matériovigilance correspondent; other health professionals use the national adverse-event reporting portal, which forwards reports to ANSM.
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Professional users and operators (and also patients and relatives) report suspected serious incidents with medical devices to BfArM via its web application or a PDF form emailed to mp-vigilanz@bfarm.de.
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Users, including doctors, pharmacists, nurses and technologists, fill in the 'White Card' (user incident reporting card for medical devices). They send it to the manufacturer's representative in Greece, with a copy to EOF's Adverse Events Department, Mesogeion 284, 155 62 Cholargos, Athens (tel. 213 204 0528).
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OGYÉI publishes an information sheet for healthcare professionals and providers on reporting device incidents, plus a forms page for medical devices.
Reporting details not yet confirmed: check the regulator's page before relying on them.
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Anyone who uses, owns or sells a device must report incidents. Healthcare professionals, users and patients are encouraged to report. Online forms are available for medical devices and for implantable devices.
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Healthcare professionals, patients and the public can report a safety issue with a medical device using the HPRA online form.
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The Ministry runs a reporting system for medical devices ('Sistema di segnalazione per i dispositivi medici') for healthcare workers and citizens, linked to the national device vigilance network (Dispovigilance).
Reporting details not yet confirmed: check the regulator's page before relying on them.
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Device users must report incidents and near-incidents to ZVA within three days and inform the manufacturer, authorised representative or distributor. The ZVA incident form is downloaded and emailed to info@zva.gov.lv.
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Professional users who detect a serious incident send the 'Meldeformular für schwerwiegende Vorkommnisse (EWR; Anwender)' to the supplier and to the Amt für Gesundheit at medical.devices@llv.li. Only anonymised patient data should be sent.
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Users report incidents on the user incident report form, sent by email (vaspvt@vaspvt.gov.lt), fax, post or courier, or in person.
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Health professionals, users and patients report serious incidents on form DPM-007-MO-001 ('Formulaire de notification d'un incident grave avec un dispositif médical / DIV') by email to meddevices.vigilance@ms.etat.lu, or by post to DPM, 2a rue Thomas Edison, L-1445 Strassen.
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Healthcare professionals use the 'Health Care Professional Incident Report Form' and members of the public use the 'Public Incident Report Form'. Both are emailed to mdvigilance.medicinesauthority@gov.mt.
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Professionals report device incidents and corrections to the inspectorate through the 'Medische hulpmiddelen: incidenten en correcties' form in Mijn IGJ, reached from the inspectorate's reporting page for professionals.
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The health service has a statutory duty to report serious incidents that have, or may have, a connection with the use of a medical device.
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Anyone can report an incident in writing. Serious incidents must be reported on the official form (Word document) by email to incydenty@urpl.gov.pl, by e-Delivery or by post.
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Healthcare professionals report incidents involving medical devices to INFARMED's National Medical Device Vigilance System (Unidade de Vigilância de Produtos de Saúde); INFARMED advises reporting whenever in doubt.
Reporting details not yet confirmed: check the regulator's page before relying on them.
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Healthcare professionals, users and patients report suspected serious incidents within 15 days, on the official form for professionals, users and patients (Word or PDF), sent to mdevice@anm.ro or by post.
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Adverse events with medical devices are reported on the electronic form 'Сообщение о неблагоприятных событиях медицинских изделий', through the personal account (Личный кабинет) on the Roszdravnadzor website, into its 'Monitoring of Medical Device Safety' system.
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Healthcare professionals report all suspected adverse reactions or incidents with medical devices, through the ALIMS online portal or on the reporting form sent by post (Vojvode Stepe 458, 11221 Belgrade). Tel. 011/3951-158.
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ŠÚKL has issued a notice reminding hospitals, healthcare professionals and healthcare providers of their duty to report accidents, malfunctions and failures of medical devices to ŠÚKL.
Reporting details not yet confirmed: check the regulator's page before relying on them.
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Healthcare professionals, users and patients report suspected serious incidents on JAZMP's online form. Healthcare professionals must report within 48 hours of discovery (ZMedPri-1, Art. 30).
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Healthcare professionals are obliged to report incidents with medical devices, and patients and users may also report. Both use the NotificaPS online portal.
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Healthcare providers must report negative events and near-incidents with medical devices both to Läkemedelsverket and to the manufacturer, using the agency's e-service form.
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Professionals who use devices report serious incidents to both the supplier and Swissmedic, using the completed user-report form (German, French or Italian) sent electronically to materiovigilance@swissmedic.ch.
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The regulator publishes information on submissions from consumers and users of medical devices, in vitro diagnostics and active implantable devices.
Reporting details not yet confirmed: check the regulator's page before relying on them.
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Anyone, including clinicians and patients, can report a suspected medical device incident (including software, apps and AI) through the Yellow Card scheme, as a guest or with an account.
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Healthcare institutions, professionals and individuals report adverse events and quality failures of medical products on ANMAT's online tecnovigilancia notification form. Do not send product samples unless asked.
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AGEMED is responsible for pharmacovigilance and technovigilance in Bolivia. Healthcare professionals should contact AGEMED directly, as no published device-reporting form or online route was found.
Reporting details not yet confirmed: check the regulator's page before relying on them.
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Health professionals report adverse events and technical complaints about health products (tecnovigilância) through Notivisa, which requires login. Citizens use e-Notivisa on gov.br.
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Health care providers report medical device incidents online or with a downloadable form; Health Canada's Medical Device Incidents database lets anyone search existing reports.
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Healthcare establishments and professionals report adverse events with medical devices to the ISP through the Integrated Surveillance System (SVI), which has had separate establishment and professional profiles since 2023. Facilities run a local network of reporters.
Reporting details not yet confirmed: check the regulator's page before relying on them.
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Under the national tecnovigilancia programme, professionals in an institution report to that institution's programme lead, who reports to INVIMA through the online Tecnovigilancia web application. Independent professionals act as their own lead. Patients report to INVIMA or to their local health secretariat.
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Under the National Technovigilance System regulation, healthcare professionals report device incidents on the official form in Annex 1. In institutions they report through the institutional technovigilance lead, who forwards reports to the Ministry of Health's National Technovigilance Centre; serious incidents are due within 24 hours.
Reporting details not yet confirmed: check the regulator's page before relying on them.
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CECMED runs post-market surveillance of medical equipment and devices in Cuba. Healthcare professionals report adverse incidents to CECMED, usually via their institution.
Reporting details not yet confirmed: check the regulator's page before relying on them.
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The Ministry of Public Health has a pharmacovigilance and technovigilance section that DIGEMAPS runs. Healthcare professionals should report device incidents through it.
Reporting details not yet confirmed: check the regulator's page before relying on them.
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Healthcare professionals and establishments download the adverse-event form (Annex 1) from the Sistema Nacional de Tecnovigilancia section of the ARCSA website and send it to ARCSA's National Technovigilance Centre by e-mail or deliver it in person. Within an establishment, the incident is first notified to the facility's technovigilance lead.
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Healthcare professionals complete the technovigilance notification form (Boleta de Notificación de Tecnovigilancia, F-FV-c-04) for adverse events or quality failures with medical devices, and send it by e-mail to the National Pharmacovigilance Programme or deliver it in person in Guatemala City.
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Health professionals report suspected adverse incidents with medical devices (tecnovigilancia) through COFEPRIS's online notification system. Separate forms exist for licence holders, patients and users, and clinical investigations.
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Medical devices in Panama are regulated by the Ministry of Health's medical devices directorate under Law 90 of 2017, separately from the pharmacy and drugs directorate (DNFD). No public device-incident reporting route for healthcare professionals was found.
Reporting details not yet confirmed: check the regulator's page before relying on them.
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Healthcare professionals and providers download DINAVISA's adverse event and incident report form for medical devices, then e-mail it to the National Technovigilance Centre or hand in a printed copy at DINAVISA's front desk.
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Healthcare professionals report suspected adverse incidents with medical devices on DIGEMID's dedicated health-professional notification form, part of the Peruvian Pharmacovigilance and Technovigilance System. In hospitals, reports normally go through the establishment's pharmacovigilance and technovigilance committee.
Reporting details not yet confirmed: check the regulator's page before relying on them.
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As a US territory, Puerto Rico falls under the FDA. Healthcare professionals report device problems voluntarily on MedWatch Form FDA 3500, online, by phone, or by post or fax; hospitals and other user facilities have mandatory reporting duties (Form 3500A).
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Health professionals, patients and consumers can voluntarily report serious device problems online or on Form FDA 3500; mandatory reporting applies to manufacturers, importers and user facilities.
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Any user, healthcare professional or company can report an adverse event or quality failure with a therapeutic medical device through an online form on the gub.uy government portal, after logging in with an electronic ID. Supporting PDF files can be attached.
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Health professionals are encouraged to report serious or suspected problems with medical devices online via the TGA's medical device incident reporting system; existing reports can be searched in the DAEN medical devices database.
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Users (mainly medical institutions), registrants and distributors report suspected device adverse events to the National Medical Device Adverse Event Monitoring Information System. Users filed about 90% of the 946,200 reports in 2024.
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Users report on the 'Medical Device Adverse Event Report Form for Medical Device Users', online or by email to mdd_air@dh.gov.hk, fax (852) 3157 1286 or post.
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Healthcare professionals, manufacturers, importers and distributors report on the Medical Device Adverse Event (MDAE) reporting form, by email to mvpi-ipc@gov.in or by post to the IPC, Ghaziabad. Helpline: 1800 180 3024. A separate form exists for consumers.
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Businesses and distribution-permit holders must report device adverse events (KTD). Users in healthcare facilities may report voluntarily. The ministry runs e-Watch Alkes as the national surveillance system for medical devices.
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Under Article 68-10(2) of the PMD Act, healthcare professionals report device malfunctions to PMDA when needed to prevent harm, preferably through PMDA's electronic reporting system. Causality need not be certain.
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Establishments must report device incidents through the MeDCReSt online system (Mandatory Problem Reporting). The page does not describe a route for healthcare facilities or clinicians.
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Anyone can report. Healthcare professionals use the Medsafe Word form for healthcare professionals and email it to devices@health.govt.nz. Separate forms exist for consumers and industry.
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Anyone can report adverse events with therapeutic goods, which include medical devices, through the Med Vigilance e-reporting system or VigiMobile. Healthcare professionals can also send the Yellow Form to npc@dra.gov.pk.
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A draft FDA circular (posted February 2026) puts the reporting duty on marketing authorisation holders. Reports sent directly by healthcare professionals or the public would be acknowledged and passed to the holder. The FDA's general complaints address is eReport@fda.gov.ph.
Reporting details not yet confirmed: check the regulator's page before relying on them.
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Healthcare professionals report medical device adverse events on HSA's online E-form. Dealers have a separate mandatory reporting form.
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Medical institution operators must report deaths and serious adverse events. Healthcare professionals, patients and consumers may report voluntarily. Reports go online through the MFDS medical device e-civil portal, or on paper by post, fax or in person.
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Suspected adverse events and product problems can be reported through TFDA's online system after registering. Medical institutions and device firms must report serious adverse events. Email: mdsafety@fda.gov.tw.
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Adverse events are reported online through HPVC's 'AE Online Reporting'. Operators need access approval (HPVC Form-8). HPVC also runs an online form for consumers.
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Medical equipment is managed under Decree 98/2021/ND-CP and its reporting templates (Circular 19/2021, consolidated as 05/VBHN-BYT).
Reporting details not yet confirmed: check the regulator's page before relying on them.
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Users, including healthcare institutions, professionals and patients, send a User Incident Report (Annex 2 of the Egyptian Guideline for Medical Device Vigilance) by email to pv.md@edaegypt.gov.eg. Healthcare institutions must appoint a contact officer.
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AMAR regulates medical devices in Israel. The Ministry's online side-effects portal covers drugs only, not devices.
Reporting details not yet confirmed: check the regulator's page before relying on them.
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PPB publishes a 'Medical Devices Diagnostics Incident Form (Green)' for reporting device incidents. Its online PvERS portal takes adverse event and quality reports.
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No official route for clinicians to report medical device incidents could be identified.
Reporting details not yet confirmed: check the regulator's page before relying on them.
Not yet confirmed
Healthcare providers detect and report device incidents on the NAFDAC Medical Device Adverse Event Reporting Form (Appendix A of the 2024 post-market surveillance guidelines), by email to pms@nafdac.gov.ng.
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MoPH regulates medical devices in Qatar, but no official route for clinicians to report device incidents could be identified.
Reporting details not yet confirmed: check the regulator's page before relying on them.
Not yet confirmed
Medical device adverse events, incidents and complaints can be reported through the National Centre for Medical Device Reporting (NCMDR), Saudi Vigilance, the 19999 call centre or the Tameni app.
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Anyone can report. Healthcare professionals use the Medical Device Adverse Event Reporting Form (GLF-MD-11A), sent to mdvigilance@sahpra.org.za (tel. 012 501 0476).
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TİTCK runs the medical device warning (vigilance) system ('Tıbbi Cihaz Uyarı Sistemi'), under which incidents (olumsuz olay) are reported.
Reporting details not yet confirmed: check the regulator's page before relying on them.
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Healthcare professionals and the public report side effects of 'medicines and medical products' online, after logging in with UAE PASS. Email and paper submissions are not accepted.
Reporting details not yet confirmed: check the regulator's page before relying on them.
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WHO does not run a global database or open reporting route for medical device incidents equivalent to VigiBase for medicines. WHO's guidance on good regulatory practices for market surveillance and vigilance (TRS 1067, Annex 9) does not mention VigiBase. It points device problems to national vigilance systems, and the only WHO global portal it names is the Global Surveillance and Monitoring System (GSMS) for substandard and falsified products. GSMS is designed for trained focal points in national regulatory authorities, not for individual clinicians (rapidalert@who.int is listed for emergencies only).
Keep the device and its packaging if you can, note the lot or serial number, and do not include the patient's name in free text. Your hospital may have its own incident system that feeds the national one. Recalls and safety notices we track are on Regulatory Watch.
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