NA 04.500.251Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10887587016894), received between Jan 2, 2019 and Feb 10, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Mechanical Jam” (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.

• MalfunctionFeb 10, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE IMPLANT DISTRACTION DEVICE DID NOT REALLY WORK LIKE IT WAS SUPPOSED TO. THERE WAS SOME PATIENT ERROR. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT STATUS AND THE OUTCOME ARE UNKNOWN. THIS IS REPORT 01 OF 04 OF (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9687008 ↗
• InjuryJan 2, 2019Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT A REVISION OF MANDIBULAR DISTRACTION BECAUSE THE CURVILINEAR DISTRACTOR STOPPED DISTRACTING SOMEWHERE BETWEEN 20-25MM. THE RIGHT ADVANCED FARTHER, DESPITE A SLOWER RATE OF DISTRACTION, AS COMPARED TO THE LEFT. THE REMOVABLE EXTENSION ARM-FLEXIBLE WAS IDENTIFIED TO BE STUCK AND COULD NOT BE DISASSEMBLED FROM THE CURVILINEAR DISTRACTOR. THE SURGEON REPLACED THE OLD DISTRACTOR, WITH A NEW ONE, TO FINISH THE DISTRACTION ON THE MANDIBLE. ORIGINAL IMPLANT DATE IS ON (B)(6) 2018. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS REPORT IS FOR ONE (1) 1.3MM CURVILINEAR DISTRACTOR R50/LEFT. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8210051 ↗