NA 40-20906SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540604644), received between Feb 10, 2020 and Apr 25, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (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.

• MalfunctionApr 25, 2023Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT WHEN THE SURGEON WENT TO INSERT SCREW TO THE HOLE THE LOCKING DID NOT WORK PROPERLY. SAME SCREW WORKED PROPERLY AT ANOTHER HOLE. THEY DID NOT INSERT ANY SCREW IN THE SCREW HOLE. THEY USED OTHER SCREW HOLES AND COMPLETED SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16805931 ↗
• MalfunctionFeb 10, 2020Difficult to Insert; Difficult to Insert

  IT WAS REPORTED, WHEN TRYING TO LOCK THE TWO SCREW HOLES IN THE SECOND ROW FROM THE DISTAL END BY LOCKING, THE PLATE AND SCREW COULD NOT BE LOCKED. THE DRILL WAS STRAIGHTENED USING A SPECIAL GUIDE, AND A SHORTER SCREW WAS INSERTED, BUT IT STILL DID NOT LOCK. THE PROCEDURE TO RE-FIX THE PLATE WAS NOT PERFORMED, AS MANY OTHER SCREWS WERE FIXED. THE PLATE WAS NOT BENT. THE PLATE WAS NOT LOADED. THERE WAS NO INTERFERENCE WITH THE OTHER SCREWS, AND NOTHING WAS CAUGHT IN THE SCREW HOLES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9690676 ↗