A new white-paper summarizing outcome data on the use of OSSDSIGN Cranial PSI in 394 cases of cranial reconstruction is now available here: https://www.ossdsign.com/us/whitepaper The data has been collected by OssDsign as part of continuous post-market surveillance efforts.
Reconstruction of cranial defects can be a complex surgical procedure associated with an underestimated morbidity. This report describes the outcome of 394 cranioplasties using OSSDSIGN Cranial PSI, a patient-specific implant made from a calcium phosphate material reinforced with 3D printed titanium. All data was collected as part of post-market surveillance following introduction of the product in Europe, US and selected Asian markets. At an average follow-up time of 14 months, 8 implants (2.0%) had been removed due to early postoperative infections and another 6 (1.5%) due to persistent wound dehiscences. None of the explantations were determined to be device related by the operating surgeon. Histological analysis of one implant explanted 31 months following surgery revealed bony integration between the implant and the native bone, as well as new bone formation within and around the remaining calcium phosphate material.
Download the full paper here: https://www.ossdsign.com/us/whitepaper