3D printing: USB patient receives first implant to be produced on-site at the hospital
University Hospital Basel achieved a new first in August by implanting a patient with an artificial calvaria (skull cap), produced specifically for him in-house at USB. After many years of research and development, USB has succeeded in becoming the first hospital in Europe to produce 3D-printed implants that meet the requirements of international standards for medical devices.
In late August, University Hospital Basel successfully fitted one of its patients with a 3D-printed prosthetic skull cap produced in-house at USB. In doing so, USB became the first hospital in Europe capable of planning, manufacturing and fitting implants that meet European quality standards.
The patient in question is a 46-year-old man who suffered a stroke in 2019. His calvaria had to be removed and reattached to provide him with treatment and began to be resorbed after a few months. This was accompanied by severe complaints and the caving in of the patient’s skull. Prof. Raphael Guzman, Head of Neurosurgery, subsequently worked closely with both the project for developing 3D-printed implants and the team led by Prof. Florian Thieringer, Consultant at the Oral and Maxillofacial Surgery Clinic. The team succeeded in manufacturing an artificial calvaria that was tailored specifically to the patient, meets the statutory requirements and was suitable for implantation in the operating theatre.
Alongside the teams at University Hospital Basel, the project was also supported by the Department of Biomedical Engineers (DBE) at the University of Basel, the Institute for Medical Engineering and Medical Informatics at the FHNW School of Life Sciences (IM2) and approval experts from POC APP AG. In this case, the goal was not “just” to meet the requirements of the Federal Medical Devices Ordinance, but also the standards of the European Union’s Medical Device Regulation (MDR).
Only a couple of weeks have passed since the successful surgery – and the patient is already feeling optimistic about his future. The doctors are closely monitoring his progress. Producing implants in-house provides significant advantages for USB. Not only does it make it possible to fine-tune interim results with the direct involvement of all parties throughout the entire process, it also significantly reduces material losses.
In the long term, USB would also like to produce more complex implants using 3D printing, such as those used in facial reconstruction or for the spinal column. “This excellent outcome for our patient shows that our years of research have paid off,” says Prof. Florian Thieringer.
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