Characterizing Adverse Events of Cranioplasty Implants After Craniectomy: A Retrospective Review of the Federal Manufacturer and User Facility Device Experience Database.

ABSTRACT

Introduction Cranioplasty is performed by placing an artificial plate in place of a patient's native skull bones to repair post-craniectomy defects after trauma. Implanted materials can range from titanium to synthetic polyether derivatives and are produced by multiple manufacturers. There are few studies characterizing complications associated with these cranioplasty plates to date. We aimed to quantify and categorize complications of these devices using a national federal database. Methods The Manufacturer and User Facility Device Experience (MAUDE) database was queried for all entries reported under the category "plate, cranioplasty, preformed, non-alterable" with the additional product code GXN between the time range from September 1, 2010, to September 1, 2020. After data extraction, each of the entries was screened for duplicates and tabulated into different categories of complications. Additionally, product information such as the plate manufacturer was extracted from each entry. Results The search yielded 329 unique event reports. The most frequent complications were infection (39%), followed by incorrectly fitting implants (30%) and implant breaks (6%). Other major complications included cerebrospinal fluid leakage and cerebral edema (5%), wound dehiscence (5%), and migration of hardware (3%). The brands associated with the most entries in the database were the Synthes (DePuy Synthes Companies, Massachusetts, United States) polyetheretherketone (PEEK) patient-specific implants (PSI) (57%), the Biomet (Zimmer Biome, Indiana, United States) hard tissue replacement-polyetherketoneketone (HTR-PEKK) patient-matched implant (PMI) (23%), and the AccuShape PEEK PSI (MedCAD, Dallas, USA) (5%). Conclusions Infection and improperly fitting implants appear to be the two most frequent complications of cranioplasty plates. The goals of future research should include the prevention of plate infections as well as improving techniques to custom-fit implantable devices.