Post-marketing surveillance of custombone service implanted in children under 7 years old

Background The CustomBone Service is a bioceramic implant suitable for cranial repair in both adults and children, although there are no clinical data about its use in children under 7 years of age. This surveillance study investigates the outcome in this age group. Method Twenty-eight children under 7 years old (range, 2.5–6 years) received CustomBone Service from July 2006 to May 2013 in 16 international hospitals. Data of 23 children (12 males and 11 females), harboring 24 prosthesis, were avail able with a minimum follow-up of 1 year. Findings Sites of the cranial defect were frontal or parietal (20.8% each), parieto-temporal (16.7%), fronto-parietal or occipital (12.5% each), fronto-parieto-temporal or fronto-temporal (8.3% each). Initial diseases were trauma (54.2%), malformation (37.5%), or tumor of the bone/skin (8.3%). Rupture of the implant occurred in a single case during the implant (1/26 surgeries, 3.8%) and the cranial repair was achieved by means of the back-up prosthesis. Five adverse events were registered during the follow-up period consisting of three cases of fracture and two of exposure/ infection of the prosthesis. All cases required the removal of the device (20.8%). Conclusions The failure rate of CustomBone Service under 7 years of age was higher than reported in adults and children over 7 years old (20.8 vs. 3.8%), However, CustomBone Service may be considered a valid option under 7 years old since other materials are burdened by more significant rates of complications in the long-term period. Due to specific properties of this material, indication to CustomBone Service in toddlers should be carefully evaluated by the surgeon on a case-by-case basis.