CLINICAL ARTICLE - PEDIATRICS Post-marketing surveillance of CustomBone Service implanted in children under 7 years old Paolo Frassanito & Gianpiero Tamburrini & Luca Massimi & Concezio Di Rocco & Angelo Nataloni & Greta Fabbri & Massimo Caldarelli Received: 26 August 2014 /Accepted: 7 October 2014 # Springer-Verlag Wien 2014 Abstract Background The CustomBone Service is a bioceramic im- plant 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 Ser- vice in toddlers should be carefully evaluated by the surgeon on a case-by-case basis. Keywords Bioceramic . Cranioplasty . Cranial repair . CustomBone . Hydroxyapatite . Decompressive craniectomy Introduction The CustomBone Service (CBS) is a customized implant constituted of macroporous hydroxyapatite, suitable for repair of cranial defect resulting from several etiologies. Though safe and effective in both adult and pediatric patients [1, 2], it is not indicated for the reconstruction of large and complex calvarial defects in children under 7 years of age. This limitation is mainly related to the prevalent growth of the skull by 5–6 years of age. Nevertheless, CBS has been anecdotally used in this age group with good results, albeit data have not been published so far. This surveillance study aims to systematically investi- gate the outcome of CBS implanted in children under 7 years of age. Materials and methods Patient population A retrospective study of all pediatric cases who underwent CBS cranioplasty between July 2006 and May 2013 was Provisional results of the present study have been presented at the Annual Meeting of the European Society for Pediatric Neurosurgery, which has been held in Rome, 4–7th May 2014. P. Frassanito (*) : G. Tamburrini : L. Massimi : C. Di Rocco : M. Caldarelli Pediatric Neurosurgery, Catholic University Medical School, Largo Agostino Gemelli, 8, 00168 Rome, Italy e-mail: paolo.frassanito@gmail.com A. Nataloni : G. Fabbri Fin-Ceramica, Faenza, Italy Acta Neurochir DOI 10.1007/s00701-014-2254-y