title: Post-marketing surveillance of CustomBone Service implanted in children under 7 years old.
abstract: 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.
  
  
  METHODS
  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 available with a minimum follow-up of 1 year.
  
  
  RESULTS
  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.
authors.affiliation: Pediatric Neurosurgery, Catholic University Medical School, Largo Agostino Gemelli, 8, 00168, Rome, Italy, paolo.frassanito@gmail.com.
authors.forename: Paolo
authors.initials: P
authors.lastname: Frassanito
authors.forename: Gianpiero
authors.initials: G
authors.lastname: Tamburrini
authors.forename: Luca
authors.initials: L
authors.lastname: Massimi
authors.forename: Concezio
authors.initials: C
authors.lastname: Di Rocco
authors.forename: Angelo
authors.initials: A
authors.lastname: Nataloni
authors.forename: Greta
authors.initials: G
authors.lastname: Fabbri
authors.forename: Massimo
authors.initials: M
authors.lastname: Caldarelli
mesh_terms: D000328:Adult; D002648:Child; D002675:Child, Preschool; D003399:Craniotomy / Q000009:adverse effects / Q000379:methods; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D040541:Marketing; D019736:Prostheses and Implants / Q000009:adverse effects* / Q000191:economics; D011475:Prosthesis Failure; D019919:Prosthesis Implantation / Q000009:adverse effects*