National Analysis of Adverse Events Involving Distal Radius Plate Systems Reported to the United States Food and Drug Administration

Hardware breakage and pain were the most frequently reported device and patient events, respectively. The distribution of reported problem-code categories varied across manufacturers, locking mechanisms, and plate subtypes. However, the observed findings are descriptive and hypothesis-generating, as MAUDE lacks exposure denominators and key clinical context, and therefore should not be interpreted as evidence of causal, comparative safety, or performance, or as recommendations for or against any specific manufacturer. Future studies with exposure data are warranted to validate these signals and evaluate comparative risks. Despite the inherent limitations of the MAUDE database, these findings present invaluable information on the reported adverse events of DRP systems and may inform proactive postoperative surveillance.