NA 04.500.230Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10887587016849), received between Oct 21, 2022 and Oct 24, 2022 — classified as 2 injuries.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2022, BILATERAL MANDIBULAR OSTEOTOMIES AND APPLICATION OF BILATERAL INTERNAL DISTRACTION DEVICES WERE PERFORMED. LEFT FACIAL ABSCESS (INFECTION) OCCURRED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 1.3MM CURVILINEAR DISTRACTOR R30/RIGHT. THIS IS REPORT 1 OF 9 FOR (B)(4).

  Patient problems: Abscess

  MAUDE report 15662610 ↗
• InjuryOct 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT HAD BILATERAL MANDIBULAR OSTOMIES AND APPLICATION OF BILATERAL INTERNAL DISTRACTION DEVICES. AN INCISION SITE INFECTION OCCURRED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 1.3MM CURVILINEAR DISTRACTOR R30/RIGHT. THIS IS REPORT 1 OF 14 FOR (B)(4).

  Patient problems: Post Operative Wound Infection

  MAUDE report 15654595 ↗