NA 460.045Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10887587055237), received between Mar 11, 2022 and Mar 11, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 11, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING A PROCEDURE, THE PIN INSIDE THE CENTER OF THE PLATE BROKE INSIDE THE PLATE AS IT WAS UNDERGOING BENDING. THREE PLATES WERE AFFECTED ALL THE SAME PART. THE PROCEDURE WAS COMPLETED. ANOTHER VENDOR¿S STERNAL SYSTEM WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO FRAGMENTS GENERATED. THERE WAS NO PATIENT OUTCOME STATUS REPORTED. THIS REPORT INVOLVES ONE (1) PLATE. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13734796 ↗
• MalfunctionMar 11, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6), 2022, DURING A PROCEDURE, THE PIN INSIDE THE CENTER OF THE PLATE BROKE INSIDE THE PLATE AS IT WAS UNDERGOING BENDING. THREE PLATES WERE AFFECTED ALL THE SAME PART. THE PROCEDURE WAS COMPLETED. ANOTHER VENDOR¿S STERNAL SYSTEM WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO FRAGMENTS GENERATED. THERE WAS NO PATIENT OUTCOME STATUS REPORTED. THIS REPORT INVOLVES ONE (1) PLATE. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13734787 ↗
• MalfunctionMar 11, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING A PROCEDURE, THE PIN INSIDE THE CENTER OF THE PLATE BROKE INSIDE THE PLATE AS IT WAS UNDERGOING BENDING. THREE PLATES WERE AFFECTED ALL THE SAME PART. THE PROCEDURE WAS COMPLETED. ANOTHER VENDOR¿S STERNAL SYSTEM WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO FRAGMENTS GENERATED. THERE WAS NO PATIENT OUTCOME STATUS REPORTED. THIS REPORT INVOLVES ONE (1) PLATE. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13734464 ↗