NA 04.500.218Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10887587016832), received between Mar 9, 2018 and Mar 9, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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.

• MalfunctionMar 9, 2018Break; Break

  IT WAS REPORTED THAT THE SURGEON WAS PREPARING THE STRAIGHT 1.3MM CURVILINEAR DISTRACTORS FOR IMPLANTATION AND THE DISTRACTION KNOB BROKE OFF ON TWO (2) DIFFERENT IMPLANTS DURING A PROCEDURE ON (B)(6) 2018. THE FRAGMENTS WERE EASILY REMOVED WITH NO ADDITIONAL INTERVENTION. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO DELAY AND WITH NO EFFECT ON PATIENT OUTCOME. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS 1 OF 2 FOR (B)(6).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7329540 ↗
• MalfunctionMar 9, 2018Break; Break

  IT WAS REPORTED THAT THE SURGEON WAS PREPARING THE STRAIGHT 1.3MM CURVILINEAR DISTRACTORS FOR IMPLANTATION AND THE DISTRACTION KNOB BROKE OFF ON TWO (2) DIFFERENT IMPLANTS DURING A PROCEDURE ON (B)(6) 2018. THE FRAGMENTS WERE EASILY REMOVED WITH NO ADDITIONAL INTERVENTION. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO DELAY AND WITH NO EFFECT ON PATIENT OUTCOME. THIS COMPLAINT INVOLVES TWO (2) DEVICES. (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7329244 ↗