NA 02.130.209Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982044631), received between Nov 1, 2019 and Nov 1, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 18, 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.

• MalfunctionNov 1, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS CLARIFIED THAT THE LOCKING SCREW IS WHAT WAS BENT. THE PLATE WAS NOT BENT. IT WAS NOTED THERE WAS A TWO (2) MINUTE SURGICAL DELAY. THE SURGEON LEFT ONE LOCKING SCREW IN DESPITE NOT LOCKING INTO THE PLATE.

  Patient problems: No Code Available

  MAUDE report 9268186 ↗
• MalfunctionNov 1, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS CLARIFIED THAT THE LOCKING SCREW IS WHAT WAS BENT. THE PLATE WAS NOT BENT. IT WAS NOTED THERE WAS A TWO (2) MINUTE SURGICAL DELAY. THE SURGEON LEFT ONE LOCKING SCREW IN DESPITE NOT LOCKING INTO THE PLATE.

  Patient problems: No Code Available

  MAUDE report 9268185 ↗