NA 04.500.271Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887587016917), received between Apr 23, 2019 and Apr 23, 2019 — classified as 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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2019Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT ON (B)(6) 2019, THE SURGEON REMOVED TWO (2) CURVILINEAR DISTRACTORS FROM THE PATIENT. THE SURGEON NOTICED THE DISTRACTORS ONLY OPENED TO 10MM AFTER CONSOLIDATION PHASE RATHER THAN THE FULL 15MM. THERE WAS NO OTHER ALLEGATION AT THE TIME OF REMOVAL. THE EVENT OCCURRED DURING THE DISTRACTION PHASE AND WAS NOT KNOWN UNTIL DISTRACTION REMOVAL. THE SURGEON TURNED THE UNKNOWN ACTIVATION ARM AND WAS NOT SURE IF THE DISTRACTOR OPENED THE FULL LENGTH. THE SURGEON IS REVIEWING CT SCAN DATA OF THE PATIENTS AIRWAY TO DETERMINE IF A SECOND OPERATION IS REQUIRED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN ACTIVATION ARM (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY 1). THIS REPORT IS FOR ONE (1) 1.3MM CURVILINEAR DISTRACTOR R70/LEFT. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8539688 ↗