Implant MR Imaging Adverse Event Analysis Report C FDA MAUDE Database Study

Yuan Ma¹, Gaohong Wu¹, Wei Sun¹, Joe Schaefer¹, Roee Lazebnik¹, Glen Sabin¹

MRI for patients with implants may cause injuries. We conducted a study analyzing FDAs MAUDE database regarding Implant MRI. We identified 87 cases of adverse events related to Implant MRI. It described deaths, life-threatening injuries, heating/burn injuries, and device malfunctions. 62% of cases were associated with active implants. 8% of identified cases were attributed to orthopedic implants. About 30% cases were associated with other types of passive metal implants or metal presence. Based on the MAUDE data, Orthopedic Implant MR imaging has relatively low occurrence of adverse events, and tends to have a low severity of harm.