Adverse Events Associated With Midface Distractors: A Review of the Manufacturer and User Facility Device Experience...

Midface distraction osteogenesis (DO) is used to correct various congenital malformations; however, published reports on associated adverse events remain limited. This study evaluates adverse events associated with midface distractors using the U.S. Food and Drug Administration's (FDA) Manufacturer and User Facility Device Experience (MAUDE) database. The MAUDE database was queried on August 5, 2025 for reports involving midface distractors from July 2015 through July 2025. Of the 77 total reports, 48 met inclusion criteria after removal of duplicate and unrelated reports. When analyzed individually, 70 unique adverse events were described within these reports. Adverse events were categorized to assess problem types and frequencies. Adverse events were classified as device-related (30.0%), patient-related (58.6%), or both (11.4%). Device-related events predominantly occurred in the postoperative period (75.9%), with breakage being the most common device-related issue (37.9%). Among patient-related events, undercorrection was the most common clinical complication (26.5%) followed by infection (16.3%). Intervention was required for 55.7% of the adverse events, with surgical correction being the most frequent (56.4%). This is the first study to objectively analyze adverse events associated with midface distractors using the MAUDE database. The present findings offer valuable insight for craniofacial surgeons to anticipate and manage complications associated with midface DO.