BONESUPPORT AB
This is an Observational Device Registry Study of CERAMENT\|G in normal use in accordance with the IFU. It will run for a period of three years from enrolment of the first patient into the Study at each Site, before being subject to review. A Device Registry is a form of observational study that concerns the performance of a device in normal use. It is intended to collect data that is reflective of 'real world' device performance.
Inclusion Criteria: * 18 years and over (on the day of surgery) * receive CERAMENT\|G as a component of their treatment at a participating, contracted centre or healthcare provider, in accordance with the IFU for the implanted product * In receipt of patient information leaflet and have signed appropriately designed informed consent form. Exclusion Criteria: * Any exclusion criteria as per IFU for CERAMENT\|G * Any off-label use
* Primary mode of action is to be a resorbable ceramic bone graft substitute intended to fill gaps and voids in the skeleton system to promote bone healing. CERAMENT ™\|G provides a void/gap filler that during the surgical procedure can augment hardware and bone alignments. * Secondary mode of action is to prevent colonization of Gentamicin sensitive microorganisms in order to protect bone healing.
Arctuva estimate
Verify or correct the compensation shown for this listing.