ChoiceSpine Implant Card Page for Patient Use

EU MDR Article 18 on Implant Cards:

The EU regulation that medical device companies must comply with to sell their products in EU and EFTA countries. Article 18 places requirements on manufacturers and Health Care Professionals regarding the information that must be provided for relevant implantable devices as well as how that information should be made available. Specifically, the manufacturer shall provide, together with the device, information allowing the identification of the device, warnings, precautions, or measures to be taken by the HCP or patient, expected lifetime and follow-up, and any other information to ensure safe use of the device by the patient. To meet EUMDR Article 18 requirements, ChoiceSpine will provide relevant medical device products with an implant card, and an implant card with label.

Medical Devices That DO NOT Require Implant Cards

• Sutures
• Screws
• Wedges
• Plates
• Pins
• Connectors

Manufacturers, Healthcare Providers (HCPs), and patients:

Manufacturers:

Provide HCPs with the following for eligible Class III implantable devices:

• Implant card(s)
• Implant card label(s)
• Implant device, warnings, and precautions can be located on the IFU.
• Implant card symbols can be found on the implant card website.

Healthcare Professionals:

Complete the implant card with:

• Name of patient or patient ID
• Date of implantation
• Name & address of healthcare institution
• HCPs give implant card(s) to the patient

Patients:

• Will be given an implant card from their Healthcare provider
• For any post-surgical follow-up questions please contact your healthcare provider
• If you have lost your card or need a replacement please contact your healthcare provider

This webpage exists to help you find the correct information related to your spinal implant device. We will go over the correct steps to both identify the spinal implant device, and how to acquire information on said spinal implant device.

You should have been given an implant card that looks like the image below.

Back of the Implant Card

Looking at the back of the implant card, find the name of the implant device at the top of the bar code. In the example below, the implant device is surrounded by an orange box.

After locating the implant device name on the back of the card, scroll down until you come across the correct accordion.
Click on the + to open the accordion, revealing eIFUs related to the product. Then, just select the eIFU that corresponds with your language.

Implant Card

One implant card will be provided per applicable product. The format is generic, and the card may be within the packaging with the implant.

Front of the card:

• Patient name or patient ID
• Space for the HCP to complete
• Date of implantation
• Name and address of HCP or institution
• How to access the implant card website address or QR code

Back of the card:

• Device Type with languages
• Space for the implant card label to be attached by the HCPs
• Name and address of manufacturer
• Manufacturer website address

Implant Label (affixed by the Healthcare Provider)

One implant label is provided by the manufacturer per applicable product which is specific to the implantable device. It contains:

• Medical Devie System Name and Device Description
• Unique Device Identification (UDI)
• Lot Number
• Expiration date (Specific to packaging sterility only)

Implant Card Symbol Legend

Name and Address of the Manufacturer

Lot Number/Batch Code

Life of the Device:

The life of ChoiceSpine’s implants to achieve clinical benefit is typically 18-24 months after implantation.  The duration for use is typically the amount of time an implant remains in the patient after fusion. Implants aren’t normally removed after fusion occurs unless recommended by the surgeon.