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

Distal radius plate (DRP) systems are the standard approach for unstable distal radius fractures, yet implant complications persist. We characterized the distribution of nationally reported device and patient adverse events by manufacturer, locking mechanism, and plate subtype using the United States Food and Drug Administration's (FDA) Manufacturer and User Facility Device Experience (MAUDE) database.

We retrospectively queried the MAUDE database for DRP-related reports using product code "HRS" (Plate, Fixation, Bone) and the term "distal radius" between January 2018 and December 2024. Follow-ups and duplicates were collapsed or removed. Device and patient problem codes were mapped to categories defined a priori. Primary outcomes included overall adverse event distribution. Secondary outcomes were stratified by manufacturer, locking mechanism (fixed vs. variable-angle), and plate subtype. Categorical comparisons were made using chi-square tests with significance defined as p<0.05.

We analyzed 582 unique reports containing 414 device-related and 520 patient-related codes. Leading device events were hardware breakage (32.6%), incompatibility/mismatch (17.9%), stability problems (13.3%), and installation/positioning failures (11.1%). Leading patient events were pain/discomfort (18.8%), peri-implant fracture (14.4%), loss of range of motion (ROM)/implant failure (12.3%), and soft-tissue injury (9.0%). By manufacturer (share of MAUDE reports in this sample: DePuy Synthes: 67.2%, Arthrex: 10.0%, Stryker: 9.8%, and Smith+Nephew: 5.7%), significant differences were observed for hardware breakage (p=0.004), incompatibility (p<0.001), installation/positioning (p<0.001), stability (p<0.001), device embedment/calcification (p<0.001), loss of ROM/implant failure (p=0.027), nerve/neurologic complications (p=0.010), pain/discomfort (p=0.001), patient reaction (p=0.002), and peri-implant fracture (p=0.015). Locking mechanism stratification identified a difference in the distribution of nerve/neurologic complication codes, with a higher proportion among reports classified as fixed-angle (p<0.001). Significant differences were observed across plate subtypes for hardware breakage (p=0.006), incompatibility (p=0.009), installation/positioning (p<0.001), and infection (p<0.001).

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.