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.
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Figure 1. Histological evidence 31 months post implantation. Paragon stained sectioning of OSSDSIGN Cranial PSI shows bony integration between the implant and the recipient bone (rb) as well as new bone formation (nb) within, and around the remaining calcium phosphate material (CaP) and supporting titanium structure (Ti).
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