NA 04.500.200Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10887587016818), received between Jul 17, 2018 and Oct 24, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Difficult to Open or Close” (1 report).

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. How this data works · Data updated Oct 13, 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, THE PATIENT UNDERWENT BILATERAL MANDIBULAR OSTEOTOMIES, APPLICATION OF BILATERAL INTERNAL DISTRACTION DEVICES, DENTAL EXTRACTIONS OF #2, 20, 31, AND A, AND RIGHT MANDIBULAR ANTROSTOMY, CAUDWELL-LUC APPROACH, TO RETRIEVE DENTAL ROOT OF #2. INTRAOPERATIVE COMPLICATIONS INCLUDED DENTAL ROOT FRACTURE REQUIRING MAXILLARY ANTROSTOMY ON THE RIGHT FOR RETRIEVAL, AND GREENSTICK FRACTURE WITH REMOVAL. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 1.3MM CURVILINEAR DISTRACTOR R100 / RIGHT. THIS IS REPORT 1 OF 12 FOR (B)(4).

  Patient problems: Bone Fracture(s); Nerve Damage

  MAUDE report 15658330 ↗
• InjuryJul 17, 2018Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN OSTEOTOMY PROCEDURE ON (B)(46 2018. THE SURGEON PLACED A CURVILINEAR DISTRACTOR ON THE MANDIBLE AND FIXATED IT WITH SCREWS. DISTRACTOR TESTING WAS PERFORMED TO CONFIRM OSTEOTOMY COMPLETION. THE DISTRACTOR COULD ACTIVATE FORWARD BUT COULD NOT REVERSE AS THE DISTRACTOR WAS DESIGNED TO DO. THE SURGEON TRIED TO DETERMINE IF BONE OR SOMETHING ELSE WAS BLOCKING THE DISTRACTOR FROM REVERSING BUT THERE WAS NO OBSTACLE. THE SURGEON DECIDED TO REMOVE THE DISTRACTOR. AFTER REMOVING THE DISTRACTOR, THE SURGEON IRRIGATED THE DISTRACTOR HEAVILY TO CONFIRM THERE WAS NOTHING CAUSING A BLOCKAGE. THE SURGEON THEN ACTIVATED THE DISTRACTOR FORWARD AND IT PERFORMED AS NORMAL, BUT THE DISTRACTOR COULD STILL NOT REVERSE. THE SURGEON THEN DETERMINED THE DISTRACTOR WAS BROKEN AND CHOSE A SMALLER DISTRACTOR (70MM) FROM THE SAME SET. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF 1 HOUR DUE TO THE REPORTED EVENT. PATIENT STATUS IS STABLE. THIS REPORT IS FOR A 1.3MM CURVILINEAR DISTRACTOR R100 / RIGHT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7695903 ↗