Users/Patients Information
Please be aware that the content of this page can vary based on the regulatory requirements in your country.
UPDATES REGARDING IMPLANTED DEVICE INFORMATION
Any updated information on implanted devices will be provided to the patients in this section. The Wishbone HA device will be properly identified with its UDI (Unique Device Identifier).
Please refer to your Implant Card (EU market only), your healthcare centre or doctor to find the UDI corresponding to your device.
IMPLANT CARD (EU MARKET ONLY)
Information present on the implant card (patient name, clinician/hospital name, date of surgery) and on the sticker to affix on the card (device name, serial number, lot number, the UDI, the device model, as well as the names, addresses and the websites of the manufacturer and distributor) shall help to identify the implanted device and report adverse event or incident.
In case of loss or degradation of the implant card, please contact your healthcare center or doctor. Wishbone SA undertakes to supply a new implant card (including the patient label containing the information related to the implanted device) to the healthcare center or doctor. The healthcare center or doctor will fill in the new implant card with the patient’s information as well as with the surgery date and will provide it to the patient.
Contact Wishbone: info@wishbone-biotech.com
PRECAUTIONS FOR PATIENTS
There are no known interactions with specific diagnostic investigations, evaluations, or therapeutic treatments or other procedures such as electromagnetic interference.
Regarding the functional lifetime of the device, no additional follow-up is required. You will be followed by your healthcare center or doctor.
SUMMARY OF SAFETY AND CLINICAL PERFORMANCE FOR PATIENTS (SSCP)
Until EUDAMED is made available, contact Wishbone SA (info@wishbone-biotech.com) for the Summary of Safety and Clinical Performance (SSCP) of the Wishbone HA device.
COMPOSITION
Wishbone HA is made from the inorganic part of bovine bones which are mainly constituted of calcium and phosphorus in the form of hydroxyapatite crystals.
ONLINE INSTRUCTIONS FOR USE (IFU)
Please be aware that the content of the instructions for use can vary based on the regulatory requirements in your country
| US market | Version | Link to online IFU | Main modifications |
|---|---|---|---|
| US IFU | Wishbone HA - IFU US market Rev01 | Not published because no products on market with this IFU revision | NA |
| US IFU | Wishbone HA - IFU US market - Rev02 | Addition of the link to the symbols glossary (section 11). Addition the cover page and the number PAC-053. | |
| US IFU | W-Bone - IFU US market - Rev03 | Modification of the trade name | |
| US IFU | W-Bone - IFU US market - Rev04 | Addition of a potential undesirable side effect identified | |
| US IFU | W-Bone - IFU US market - Rev05 | Modification of the device description: “Bovine bone graft” instead “Bone graft material” and removal of distributor and importer information | |
| EU market | Version | Link to online IFU | Main modifications | |
|---|---|---|---|---|
| EU IFU | The IFU, once approved by the Notified Body, will be posted on Wishbone SA website | / | / | |
| EU IFU | Wishbone HA - IFU EU - Clinical investigation CIV-24-01-045555 | This is the IFU of the clinical investigation (CIV-24-01-045555) approved by the FAMHP. | ||